The consumer decision journey - McKinsey & Company

If marketing has one goal, it’s to reach consumers at the moments that most influence their decisions. That’s why consumer electronics companies make sure not only that customers see their televisions in stores but also that those televisions display vivid high-definition pictures. It’s why Amazon.com, a decade ago, began offering targeted product recommendations to consumers already logged in and ready to buy. And it explains P&G’s decision, long ago, to produce radio and then TV programs to reach the audiences most likely to buy its products—hence, the term “soap opera.”

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Marketing has always sought those moments, or touch points, when consumers are open to influence. For years, touch points have been understood through the metaphor of a “funnel”—consumers start with a number of potential brands in mind (the wide end of the funnel), marketing is then directed at them as they methodically reduce that number and move through the funnel, and at the end they emerge with the one brand they chose to purchase (Exhibit 1). But today, the funnel concept fails to capture all the touch points and key buying factors resulting from the explosion of product choices and digital channels, coupled with the emergence of an increasingly discerning, well-informed consumer. A more sophisticated approach is required to help marketers navigate this environment, which is less linear and more complicated than the funnel suggests. We call this approach the consumer decision journey. Our thinking is applicable to any geographic market that has different kinds of media, Internet access, and wide product choice, including big cities in emerging markets such as China and India.

We developed this approach by examining the purchase decisions of almost 20,000 consumers across five industries and three continents. Our research showed that the proliferation of media and products requires marketers to find new ways to get their brands included in the initial-consideration set that consumers develop as they begin their decision journey. We also found that because of the shift away from one-way communication—from marketers to consumers—toward a two-way conversation, marketers need a more systematic way to satisfy customer demands and manage word-of-mouth. In addition, the research identified two different types of customer loyalty, challenging companies to reinvigorate their loyalty programs and the way they manage the customer experience.

Finally, the research reinforced our belief in the importance not only of aligning all elements of marketing—strategy, spending, channel management, and message—with the journey that consumers undertake when they make purchasing decisions but also of integrating those elements across the organization. When marketers understand this journey and direct their spending and messaging to the moments of maximum influence, they stand a much greater chance of reaching consumers in the right place at the right time with the right message.

How consumers make decisions

Every day, people form impressions of brands from touch points such as advertisements, news reports, conversations with family and friends, and product experiences. Unless consumers are actively shopping, much of that exposure appears wasted. But what happens when something triggers the impulse to buy? Those accumulated impressions then become crucial because they shape the initial-consideration set: the small number of brands consumers regard at the outset as potential purchasing options.

The funnel analogy suggests that consumers systematically narrow the initial-consideration set as they weigh options, make decisions, and buy products. Then, the postsale phase becomes a trial period determining consumer loyalty to brands and the likelihood of buying their products again. Marketers have been taught to “push” marketing toward consumers at each stage of the funnel process to influence their behavior. But our qualitative and quantitative research in the automobile, skin care, insurance, consumer electronics, and mobile-telecom industries shows that something quite different now occurs.

Actually, the decision-making process is a more circular journey, with four primary phases representing potential battlegrounds where marketers can win or lose: initial consideration; active evaluation, or the process of researching potential purchases; closure, when consumers buy brands; and postpurchase, when consumers experience them (Exhibit 2). The funnel metaphor does help a good deal—for example, by providing a way to understand the strength of a brand compared with its competitors at different stages, highlighting the bottlenecks that stall adoption, and making it possible to focus on different aspects of the marketing challenge. Nonetheless, we found that in three areas profound changes in the way consumers make buying decisions called for a new approach.

Brand consideration

Imagine that a consumer has decided to buy a car. As with most kinds of products, the consumer will immediately be able to name an initial-consideration set of brands to purchase. In our qualitative research, consumers told us that the fragmenting of media and the proliferation of products have actually made them reduce the number of brands they consider at the outset. Faced with a plethora of choices and communications, consumers tend to fall back on the limited set of brands that have made it through the wilderness of messages. Brand awareness matters: brands in the initial-consideration set can be up to three times more likely to be purchased eventually than brands that aren’t in it.

Not all is lost for brands excluded from this first stage, however. Contrary to the funnel metaphor, the number of brands under consideration during the active-evaluation phase may now actually expand rather than narrow as consumers seek information and shop a category. Brands may “interrupt” the decision-making process by entering into consideration and even force the exit of rivals. The number of brands added in later stages differs by industry: our research showed that people actively evaluating personal computers added an average of 1 brand to their initial-consideration set of 1.7, while automobile shoppers added 2.2 to their initial set of 3.8 (Exhibit 3). This change in behavior creates opportunities for marketers by adding touch points when brands can make an impact. Brands already under consideration can no longer take that status for granted.

Empowered consumers

The second profound change is that outreach of consumers to marketers has become dramatically more important than marketers’ outreach to consumers. Marketing used to be driven by companies; “pushed” on consumers through traditional advertising, direct marketing, sponsorships, and other channels. At each point in the funnel, as consumers whittled down their brand options, marketers would attempt to sway their decisions. This imprecise approach often failed to reach the right consumers at the right time.

In today’s decision journey, consumer-driven marketing is increasingly important as customers seize control of the process and actively “pull” information helpful to them. Our research found that two-thirds of the touch points during the active-evaluation phase involve consumer-driven marketing activities, such as Internet reviews and word-of-mouth recommendations from friends and family, as well as in-store interactions and recollections of past experiences. A third of the touch points involve company-driven marketing (Exhibit 4). Traditional marketing remains important, but the change in the way consumers make decisions means that marketers must move aggressively beyond purely push-style communication and learn to influence consumer-driven touch points, such as word-of-mouth and Internet information sites.

The experience of US automobile manufacturers shows why marketers must master these new touch points. Companies like Chrysler and GM have long focused on using strong sales incentives and in-dealer programs to win during the active-evaluation and moment-of-purchase phases. These companies have been fighting the wrong battle: the real challenges for them are the initial-consideration and postpurchase phases, which Asian brands such as Toyota Motor and Honda dominate with their brand strength and product quality. Positive experiences with Asian vehicles have made purchasers loyal to them, and that in turn generates positive word-of-mouth that increases the likelihood of their making it into the initial-consideration set. Not even constant sales incentives by US manufacturers can overcome this virtuous cycle.

Two types of loyalty

When consumers reach a decision at the moment of purchase, the marketer’s work has just begun: the postpurchase experience shapes their opinion for every subsequent decision in the category, so the journey is an ongoing cycle. More than 60 percent of consumers of facial skin care products, for example, go online to conduct further research after the purchase—a touch point unimaginable when the funnel was conceived.

Although the need to provide an after-sales experience that inspires loyalty and therefore repeat purchases isn’t new, not all loyalty is equal in today’s increasingly competitive, complex world. Of consumers who profess loyalty to a brand, some are active loyalists, who not only stick with it but also recommend it. Others are passive loyalists who, whether from laziness or confusion caused by the dizzying array of choices, stay with a brand without being committed to it. Despite their claims of allegiance, passive consumers are open to messages from competitors who give them a reason to switch.

Take the automotive-insurance industry, in which most companies have a large base of seemingly loyal customers who renew every year. Our research found as much as a sixfold difference in the ratio of active to passive loyalists among major brands, so companies have opportunities to interrupt the loyalty loop. The US insurers GEICO and Progressive are doing just that, snaring the passively loyal customers of other companies by making comparison shopping and switching easy. They are giving consumers reasons to leave, not excuses to stay.

All marketers should make expanding the base of active loyalists a priority, and to do so they must focus their spending on the new touch points. That will require entirely new marketing efforts, not just investments in Internet sites and efforts to drive word-of-mouth or a renewed commitment to customer satisfaction.

Aligning marketing with the consumer decision journey

Developing a deep knowledge of how consumers make decisions is the first step. For most marketers, the difficult part is focusing strategies and spending on the most influential touch points. In some cases, the marketing effort’s direction must change, perhaps from focusing brand advertising on the initial-consideration phase to developing Internet properties that help consumers gain a better understanding of the brand when they actively evaluate it. Other marketers may need to retool their loyalty programs by focusing on active rather than passive loyalists or to spend money on in-store activities or word-of-mouth programs. The increasing complexity of the consumer decision journey will force virtually all companies to adopt new ways of measuring consumer attitudes, brand performance, and the effectiveness of marketing expenditures across the whole process.

Without such a realignment of spending, marketers face two risks. First, they could waste money: at a time when revenue growth is critical and funding tight, advertising and other investments will be less effective because consumers aren’t getting the right information at the right time. Second, marketers could seem out of touch—for instance, by trying to push products on customers rather than providing them with the information, support, and experience they want to reach decisions themselves.

Four kinds of activities can help marketers address the new realities of the consumer decision journey.

Prioritize objectives and spending

In the past, most marketers consciously chose to focus on either end of the marketing funnel—building awareness or generating loyalty among current customers. Our research reveals a need to be much more specific about the touch points used to influence consumers as they move through initial consideration to active evaluation to closure. By looking just at the traditional marketing funnel’s front or back end, companies could miss exciting opportunities not only to focus investments on the most important points of the decision journey but also to target the right customers.

In the skin care industry, for example, we found that some brands are much stronger in the initial-consideration phase than in active evaluation or closure. For them, our research suggests a need to shift focus from overall brand positioning—already powerful enough to ensure that they get considered—to efforts that make consumers act or to investments in packaging and in-store activities targeted at the moment of purchase.

Tailor messaging

For some companies, new messaging is required to win in whatever part of the consumer journey offers the greatest revenue opportunity. A general message cutting across all stages may have to be replaced by one addressing weaknesses at a specific point, such as initial consideration or active evaluation.

Take the automotive industry. A number of brands in it could grow if consumers took them into consideration. Hyundai, the South Korean car manufacturer, tackled precisely this problem by adopting a marketing campaign built around protecting consumers financially by allowing them to return their vehicles if they lose their jobs. This provocative message, tied to something very real for Americans, became a major factor in helping Hyundai break into the initial-consideration set of many new consumers. In a poor automotive market, the company’s market share is growing.

Invest in consumer-driven marketing

To look beyond funnel-inspired push marketing, companies must invest in vehicles that let marketers interact with consumers as they learn about brands. The epicenter of consumer-driven marketing is the Internet, crucial during the active-evaluation phase as consumers seek information, reviews, and recommendations. Strong performance at this point in the decision journey requires a mind-set shift from buying media to developing properties that attract consumers: digital assets such as Web sites about products, programs to foster word-of-mouth, and systems that customize advertising by viewing the context and the consumer. Many organizations face the difficult and, at times, risky venture of shifting money to fundamentally new properties, much as P&G invested to gain radio exposure in the s and television exposure in the s.

Broadband connectivity, for example, lets marketers provide rich applications to consumers learning about products. Simple, dynamic tools that help consumers decide which products make sense for them are now essential elements of an online arsenal. American Express’s card finder and Ford’s car configurator, for example, rapidly and visually sort options with each click, making life easier for consumers at every stage of the decision journey. Marketers can influence online word-of-mouth by using tools that spot online conversations about brands, analyze what’s being said, and allow marketers to post their own comments.

Finally, content-management systems and online targeting engines let marketers create hundreds of variations on an advertisement, taking into account the context where it appears, the past behavior of viewers, and a real-time inventory of what an organization needs to promote. For instance, many airlines manage and relentlessly optimize thousands of combinations of offers, prices, creative content, and formats to ensure that potential travelers see the most relevant opportunities. Digital marketing has long promised this kind of targeting. Now we finally have the tools to make it more accurate and to manage it cost effectively.

Win the in-store battle

Our research found that one consequence of the new world of marketing complexity is that more consumers hold off their final purchase decision until they’re in a store. Merchandising and packaging have therefore become very important selling factors, a point that’s not widely understood. Consumers want to look at a product in action and are highly influenced by the visual dimension: up to 40 percent of them change their minds because of something they see, learn, or do at this point—say, packaging, placement, or interactions with salespeople.

In skin care, for example, some brands that are fairly unlikely to be in a consumer’s initial-consideration set nonetheless win at the point of purchase with attractive packages and on-shelf messaging. Such elements have now become essential selling tools because consumers of these products are still in play when they enter a store. That’s also true in some consumer electronics segments, which explains those impressive rows of high-definition TVs in stores.

Sometimes it takes a combination of approaches—great packaging, a favorable shelf position, forceful fixtures, informative signage—to attract consumers who enter a store with a strong attachment to their initial-consideration set. Our research shows that in-store touch points provide a significant opportunity for other brands.

Integrating all customer-facing activities

In many companies, different parts of the organization undertake specific customer-facing activities—including informational Web sites, PR, and loyalty programs. Funding is opaque. A number of executives are responsible for each element, and they don’t coordinate their work or even communicate. These activities must be integrated and given appropriate leadership.

The necessary changes are profound. A comprehensive view of all customer-facing activities is as important for business unit heads as for CEOs and chief marketing officers. But the full scope of the consumer decision journey goes beyond the traditional role of CMOs, who in many companies focus on brand building, advertisements, and perhaps market research. These responsibilities aren’t going away. What’s now required of CMOs is a broader role that realigns marketing with the current realities of consumer decision making, intensifies efforts to shape the public profiles of companies, and builds new marketing capabilities.

Consider the range of skills needed to manage the customer experience in the automotive-insurance industry, in which some companies have many passive loyalists who can be pried away by rivals. Increasing the percentage of active loyalists requires not only integrating customer-facing activities into the marketing organization but also more subtle forms of organizational cooperation. These include identifying active loyalists through customer research, as well as understanding what drives that loyalty and how to harness it with word-of-mouth programs. Companies need an integrated, organization-wide “voice of the customer,” with skills from advertising to public relations, product development, market research, and data management. It’s hard but necessary to unify these activities, and the CMO is the natural candidate to do so.

Marketers have long been aware of profound changes in the way consumers research and buy products. Yet a failure to change the focus of marketing to match that evolution has undermined the core goal of reaching customers at the moments that most influence their purchases. The shift in consumer decision making means that marketers need to adjust their spending and to view the change not as a loss of power over consumers but as an opportunity to be in the right place at the right time, giving them the information and support they need to make the right decisions.

• General Requirements
• Requirements for Records and Reporting
• Acknowledgement Letters and Accession Numbers
• Performance Standards and Certification
• Industry Guidance
• Standards and Requirements for Electronic Products
• Importation of Electronic Products
• Product Specific Questions
• Getting More Information

General Requirements

Q1) What products are regulated as electronic products that emit radiation?

Examples of products that are regulated as electronic products that emit radiation include diagnostic x-ray systems, laser products, laser light shows, microwave ovens, cabinet x-ray systems, sunlamps and sunlamp products (tanning beds and booths), mercury vapor lamps, germicidal ultraviolet lamps, light emitting diodes (LED), and people scanners. For purposes of the FDA's electronic product radiation control program, the terms "electronic product" and "electronic product radiation" are defined at 21 CFR .3(j) and (k) respectively. See more Examples of Radiation-Emitting Electronic Products on our website.

Q2) Who has regulatory authority over the manufacture and use of radiation-emitting electronic products?

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products within the scope of its authority under Chapter V, Subchapter C, of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (Chapter 9, Subchapter V, Part C, of Title 21 of the United States Code (U.S.C.)). The CDRH goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. For most electronic products, safety regulation is divided between CDRH and state regulatory agencies. CDRH regulates the manufacture of the products, and the states regulate the use of the products.

For additional information on CDRH regulations that apply to manufacturers of electronic products see the Laws and Regulations (Radiation-Emitting Products) webpage.

Suggested State Regulations for Control of Radiation is a document provided by the Conference of Radiation Control Program Directors, Inc. (CRCPD), see SSRCRs - CRCPD. CRCPD's website also contains contact information for each state's regulatory agency (see map).  

Note: Manufacturers may be subject to additional FDA regulations for products intended to be used in a medical application (medical devices) or for irradiation or inspection of food (Title 21 CFR Part 179 Food Irradiation), which are beyond the scope of this document.

Q3) What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products and what are the regulatory requirements?

The FDA's statutory authority to regulate radiation-emitting electronic products is granted by Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control.

Title 21 of the Code of Federal Regulations (CFR), Chapter I, Subchapter J, Parts through (21 CFR Parts – ) contains radiation safety regulations for manufacturers of radiation-emitting electronic products.

Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation. All manufacturers of electronic products must comply with the applicable requirements in 21 CFR Parts , , , and .

If a mandatory radiation safety performance standard applies to a manufacturer's product, then the manufacturer must also comply with 21 CFR Part and the product must comply with the requirements of the standard.

Mandatory radiation safety performance standards are found in 21 CFR Parts – .

Q4) What other Federal Agencies are involved in radiation safety?

Other Federal Agencies involved with radiation safety include the:

• U.S. Environmental Protection Agency (EPA)
• U.S. Occupational Health and Safety Administration (OSHA)
• National Institutes of Occupational Safety and Health (NIOSH)
• U.S. Nuclear Regulatory Commission (NRC)

Q5) Am I a manufacturer?

Manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products. 21 CFR .3(n).

Requirements for Records and Reporting

Q6) Am I required to maintain records and submit reports for radiation- emitting electronic products to CDRH?

Yes. Manufacturers are required to maintain records and submit reports to CDRH for their electronic products that emit radiation. The specific requirements for reporting and record keeping are listed by product in Table 1 of 21 CFR .1.

Please review the Records and Reporting (Radiation-Emitting Products) webpage for additional information regarding reports required prior to introduction of a radiation-emitting electronic product into United States interstate commerce.

Q7) When do I have to submit the product, supplemental, or abbreviated report required for my new product?

Your product, supplemental, or abbreviated report must be submitted prior to introduction of the product into interstate commerce. Early submission of your report increases the probability that CDRH can contact you about problems before you sell your product.

If your product is an import, please send in your report at least one month before you present your products for import. This allows CDRH time to provide an acknowledgement of receipt letter which will include the report's accession number. An accession number is a unique identification number for your report assigned by the CDRH Document Control Center (DCC) staff when the report is received.

Q8) When do I have to submit my Annual Report?

In accordance with 21 CFR .13, Annual Reports are due each year by September 1 and must cover the 12-month period ending on June 30 of the year submitted. In other words, a report submitted on September 1, must cover the time period from July 1, through June 30, . Reporting forms and guides for Annual Reports are available in FDA eSubmitter. More information on each product area is available on the A-Z List of Regulated Products & Procedures on our website.

There is a 2-month "grace" period between June 30th and September 1st of each year when the annual report submitted by September 1 of the previous year is still valid while the manufacturer prepares a report due by September 1 of the current year. For example, an annual report for July 1, - June 30, that was submitted by September 1, , is still valid through September 1, .

Reports can be sent by to .

Q9) When my company sells a regulated product line to another company, how do we inform CDRH?

Your company can inform CDRH by submitting an Annual Report to "close out" either a particular model or your entire involvement in the electronic product manufacturing business.

Situation 1: A firm makes a radiation-emitting electronic product (one or a cluster of many) and then stops making electronic products. They file one more Annual Report and say they are now out of the business of making electronic products. No more Annual Reports are expected unless they resume making electronic products.

Situation 2: A firm makes one or several electronic products and then stops making them, but still makes others. They still need to submit Annual Reports, but the models they stopped are marked as discontinued effective on a certain date. We no longer expect to find those models in the Annual Report.

If your company prefers not to wait to submit an Annual Report, you may also submit a letter listing all the models and Accession numbers that are being acquired by another company. This letter serves as a report supplement for each Accession number and the CDRH Document Control Center (DCC) will update each Accession number to reflect the new ownership. Manufacturers are required to submit product reports on the electronic products they manufacture and certify to the performance standard, per 21 CFR .10. So a new manufacturer may submit a new stand-alone report on the product or might submit a new supplement for each model describing any changes introduced by the firm that affects its compliance to the performance standard, such as component changes, the new certification and identification label, other required labels, the firm's own quality control inspection & testing procedures, and a new Operator's manual as soon as they are printed.

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Q10) When do the Radiological Health reporting responsibilities begin after a model or product line changes hands?

As soon as the new company begins manufacturing the acquired product, it is responsible for assuring that the product complies with any applicable performance standard, including standards that apply to the development and implementation of an in-house quality control inspection and testing programs and ensuring products that comply with applicable performance standards carry a certification label or tag prior to marketing.

The company is also required to submit its own radiation safety product report demonstrating how the product complies. Initially, it would be acceptable to reference the previous manufacturer's product report. However, as the new company may modify components, testing procedures, labels, and user/service instructions, the new company must submit its own documentation.

Q11) How should a company get the reports submitted by the previous company transferred to the new company?

When electronic products are transferred from one company to another, it is appropriate to have the records transferred as well. A letter or on company letterhead sent to the CDRH/DCC identifying the models and report accession numbers that should be transferred to the new company's name and contact information will assure that the CDRH database is updated to reflect the new ownership. However, be aware that the new company is also required to submit its own radiation safety product report demonstrating how the product complies including whether any modifications have been made to components, testing procedures, labels, or user/service instructions.

Q12) Where do I send my report?

You may your report to , submit the report via the Electronic Submissions Gateway portal,

OR send your report to our mailing address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center - WO66-G609
New Hampshire Avenue
Silver Spring, MD -

Q13) May I submit radiation safety reports and correspondence to CDRH by ?

Yes, all Radiation Safety reports may now be submitted to CDRH by to the mailbox, including:

• product reports,
• annual reports,
• supplemental reports of all types,
• notifications of defect/failure to comply,
• corrective action plan (CAP) proposals, and
• accidental radiation occurrences (AROs).

Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures, and attached to your . eSubmissions no longer need to be transferred to a physical medium and mailed to the CDRH Document Control Center (DCC). An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account.

Do not use the Rad Health Customer Service mailbox to submit any other type of submission to the Center for Devices and Radiological Health, such as Premarket Approval Applications, De Novo classification requests, Premarket Notification Submissions ("510(k)s") or Electronic Medical Device Reporting (eMDR) submissions.

For more information on Radiological Health reports, please review the CDRH Learn Modules: How to Get your Electronic Product to the US Market and Electronic Product Certification and Quality Testing Programs.

Q14) If I want to sell my product immediately, is it acceptable to initially submit an incomplete product report?

No. The reports you submit must contain all of the information required by the applicable regulations (see 21 CFR .10 through .12). If CDRH has published a reporting guide for your product, please follow the format and organization in the reporting guide when preparing your report. Reporting guides are available at FDA eSubmitter. You may refer to Records and Reporting (Radiation-Emitting Products) web site or use the FDA eSubmitter electronic reports software to prepare your report.

Acknowledgement Letters and Accession Numbers

Q15) What is the purpose of the acknowledgement of receipt letter?

The CDRH acknowledgement of receipt letter is intended to inform you:

• That your report has been received;
• That your report has been entered into our database;
• Of the Product Code assigned to your report; and
• Of your report's accession number.

An acknowledgement of receipt letter is not an approval of your product nor does it mean that your report is adequate.

Q16) What is an accession number?

Accession numbers are unique identifiers for reports in our database and are provided in the CDRH acknowledgement of receipt letters. An accession number facilitates communication about specific reports because all parties can use the accession number to identify the document being discussed. Additionally, FDA imports staff use accession numbers to confirm that a manufacturer has, at a minimum, complied with the self-certification and reporting requirements for the product being imported.

Q17) Does an accession number for my report mean that CDRH has approved my product?

No. An accession number means that your report has been received by CDRH Document Control Center (DCC), and some information about the manufacturer and product were entered into our database.

Q18) Where are acknowledgement of receipt letters sent?

Acknowledgement of receipt letters are returned to the address provided for the report submitter. Only one copy of the letter is sent. If the submitter is different from the manufacturer, the letter is only sent to the report submitter. The submitter may send a copy to the manufacturer.

Q19) How long after I submit my report may I expect to receive an acknowledgement of receipt letter from CDRH?

You should receive an acknowledgement of receipt letter within four weeks after you emailed or mailed your product report, abbreviated report, annual report or supplemental report. Please wait at least four weeks before making an inquiry. If you have not received your acknowledgement of receipt letter after four weeks from the date you submitted your report, you may contact CDRH at:

Center for Devices and Radiological Health
Document Mail Center - WO66-G609
New Hampshire Avenue
Silver Spring, MD -
: .

If you contact us, please provide us the names of the manufacturer and submitter, the model name or number, the date the report was sent, the exact address you used, the name of mail service used, and any associated tracking number. We will not respond to inquiries received less than four weeks from the date you sent the report.

If you submit your report electronically, an acknowledgement message will be sent out as soon as the submission is successfully loaded into the CDRH database. Typically, an electronic report is loaded within one day of receipt.

Q20) Is there something I can do to assure a faster acknowledgement of receipt letter of my report?

Yes. We have electronic submissions software, eSubmitter, for all documents required by the Radiological Health program in CDRH. Reports prepared and submitted using this software may be acknowledged significantly faster than a traditional report submitted on paper. You may use the FDA eSubmitter to submit documents electronically. The FDA eSubmitter software correctly packages and the FDA Gateway authenticates and validates electronic submissions for routing to CDRH.

Q21) Do I have to wait until I receive an acknowledgement letter with my accession number before I can begin shipping my products to customers?

No. However, you are required to submit reports to CDRH before introducing products into United States commerce. The acknowledgement of receipt letter and accession number are evidence that the report was received by CDRH. If your product is made in another country for import into the United States, the import clearance process requests identification of the accession number on the import affirmation form, FDA , when that form is required. The form FDA is available at: FDA Forms.

Q22) How long does it take for CDRH to approve my product after a report receives an accession number?

CDRH does not have the authority to approve the radiation safety of an electronic product that emits radiation. You may not receive a technical review about your product report. If CDRH has not contacted you about your report, it means that we have not identified any significant deficiencies with the report or questions about your product.

It may take at least four weeks after you mailed your report to receive your acknowledgement of receipt letter that contains your accession number. Neither the acknowledgement of receipt letter nor the accession number constitutes an approval of your product.

Q23) Will CDRH contact me after review of my report?

CDRH will not contact you unless we have specific questions about your product or report.

Performance Standards and Certification

Q24) What is certification?

Certification means that the manufacturer of a radiation-emitting electronic product states that the product complies with an applicable FDA performance standard and does not emit hazardous and unnecessary radiation. Certification is based upon the manufacturer's own quality control testing program and does not indicate FDA approval.

Q25) Does the FDA approve the certification of my product?

No. Certification is a manufacturer's statement that indicates its product complies with the applicable standard. The manufacturer is responsible for assuring the certification (21 CFR ) that a product complies with an applicable standard is true to the best of its knowledge. This statement of certification must be based on a quality control and testing program which can demonstrate that each product manufactured complies with the applicable standard.

Note: The only routine communication sent by CDRH regarding radiation safety is an acknowledgement of receipt letter (see Q11). Only manufacturers with safety issues or potential safety issues receive letters from the FDA.

Q26) How do I know if an FDA performance standard applies to my product?

Table 1 of 21 CFR .1 shows a list of products followed by a reference to any applicable standard. Mandatory radiation safety performance standards are contained in 21 CFR Parts through . The first section of each standard defines and describes products subject to that standard.

Q27) What if no FDA performance standard applies to my product?

It is always the manufacturer's responsibility to produce an electronic, radiation-emitting product that does not emit hazardous and unnecessary radiation and to comply with the general requirements in 21 CFR through . If there is no performance standard associated with the product, the manufacturer may still have certain reporting requirements, see Table 1 of 21 CFR .1.

Laser Standards and International Standards

Q28) For products with an applicable FDA mandatory radiation safety performance standard, are there any other standards that FDA will accept?

All products with an applicable radiation safety performance standard must comply with the FDA's standard before entering the U.S. or its territories. The FDA provisionally does not intend to enforce the requirements of certain sections of 21 CFR .10 and .11 if laser products are certified through conformance to the relevant portions of IEC -1 Ed. 3 and IEC -2-22 Ed. 3.1 identified in Laser Notice 56. Note that, as announced on June 7, , FDA was transitioning to Laser Notice 56 from Laser Notice 50 (LN 50), which was withdrawn on December 31, .

Please see information on Laser Notices to Industry on the Notices to the Laser Industry web page.

Some program areas, such as the diagnostic X-ray products, may have posted guidance documents that recognize international standards and/or provide guidance on certain reporting requirements. The FDA does not recognize regulatory approvals from other countries or other organizations.

Q29) For products that have been reported under the withdrawn Laser Notice 50, do we need to resubmit product reports and supplemental reports under Laser Notice 56 and change the certification label or tag on the products?

No, you do not have to resubmit product reports or supplemental reports. However, if the compliance of your firm's laser products changes as a result of certifying products using Laser Notice 56, then you must submit a supplemental report. In accordance with 21 CFR .11(b), you must report any changes to the product compared with the initial product report or laser supplemental report. Examples of changes include but are not limited to minimal changes such as updated emission values for classification and labeling (including the certification label or tag as per Laser Notice 56), or substantial changes such as a new laser class resulting from changes to performance features, labeling, quality test program, or user information.

Q30) What is the status of products for which the reports were submitted while Laser Notice 50 was in effect after the withdrawal of Laser Notice 50?

Laser products properly certified using Laser Notice 50 on or before the December 31, withdrawal date may be entered into U.S. commerce on January 1, and thereafter. After December 31, , only laser products that are properly certified to comply with the applicable laser standards set forth in 21 CFR .10 and .11 or that conform to the relevant portions of IEC -1 Ed. 3 and IEC -2-22 Ed. 3.1 may be entered into U. S. commerce. The relevant portions of IEC -1 Ed. 3 and IEC -2-22 Ed. 3.1 are identified in Laser Notice 56.

Q31) Do laser products certified in accordance with Laser Notice 50 before its withdrawal need to be re-designed, re-evaluated and re-certified in accordance with Laser Notice 56 since Laser Notice 50 was withdrawn?

No. Any laser product properly certified using Laser Notice 50 before January 1, , may be entered into U.S. commerce upon submission of a product report; it does not need to be re-designed, re-evaluated, or re-certified to the FDA laser performance standard, or using Laser Notice 56. Should a manufacturer not be able to certify its laser products without using Laser Notice 50 after December 31, , the manufacturer may apply for a variance.

Q32) May a laser-illuminated projector be certified to comply with the FDA laser performance standard using Laser Notice 50?

No. Laser Notice 57 was published on May 8, , and superseded prior notices on laser-illuminated projectors (LIPs). Laser Notice 57 was drafted with input from members of industry, as was the IEC LIP vertical standard, IEC -5, which is referenced in Laser Notice 57. The FDA determined that Laser Notice 57 represents the most appropriate means for certifying these special purpose laser products. Specifically, Laser Notice 57 directs the use of IEC -1: Subclause 4.4, which describes suitability for classification using the IEC lamp standard, IEC . Should the conditions in Subclause 4.4 not be met, LIP manufacturers would then use IEC -1:, Subclause 4.3 for laser classification. Laser Notice 50 cannot be used with Laser Notice 57.

Q33) How do I contact the FDA for questions about the use of Laser Notice 50, 56 or 57?

Please any questions about radiation-emitting electronic products, including those about Laser Notices, to .

Standards and Requirements for Electronic Products

Q34) We make thousands of products a year; do we have to test each one?

Not necessarily. When appropriate, you may use a statistically valid sampling plan as a part of your quality control and testing program that conforms to appropriate consensus standards on quality control sampling.

Q35) When am I allowed to sell my product in the United States?

You may sell your product when you have assured your product does not emit hazardous and unnecessary radiation. Additionally, if there is an applicable mandatory federal radiation safety performance standard:

• Your product must comply with the applicable performance standards;
• You must establish a testing and quality control program sufficient to prove your product is completely compliant with its applicable standard (21 CFR Parts through ); and
• Your product must have certification and identification information permanently affixed or inscribed as required in the general performance standard (21 CFR Paty ). You may only place a certification label or tag on a product if your certification is based on an adequate quality control and testing program. The certification label or tag is your statement that your product conforms to the applicable standard (21 CFR Part .2).

Q36) I want to import a medical laser product (or other medical radiation-emitting product), what do I need to do to get it approved for U.S. market?

Because these products are medical devices, they must also comply with the medical device regulations, including establishment registration and device listing requirements and applicable premarket review requirements.

For more information, see Device Advice: Comprehensive Regulatory Assistance webpage, "How to Study and Market Your Device."

Q37) What standards and requirements are applicable to components of electronic products?

Some components are subject to mandatory performance standards and reporting requirements.

For example, diagnostic x-ray components identified in 21 CFR .30(a)(1)(i) must comply with specific requirements in 21 CFR .30 and be certified.

Laser components are exempt from the mandatory performance standard in 21 CFR .10 and .11, if they meet specific applicability requirements identified in 21 CFR .10(a), including the laser component manufacturer registering their firm and identifying their products by submitting a document as described in 21 CFR .10(a)(3) and maintaining distribution records.

Only the diagnostic x-ray and laser standards have specific requirements for components (certification or registration). For all other products, 21 CFR .10, .11, .12, and .13 apply to systems regardless of whether the system requires assembly by the user or are provided to the user as fully assembled systems.

Importation of Electronic Products

Q38) What form do I need to submit to the FDA Imports office to import my product into the U.S.?

Importers of radiation-emitting electronic products subject to an FDA performance standard are required to submit a written declaration on "Declaration of Products Subject to Radiation Control Standards," form FDA , along with other import entry information, through U.S. Customs and Border Protection (CBP) to the appropriate FDA imports office. Radiation-emitting electronic products that fail to comply with the applicable performance standard or that do not have a certification label or tag (as required by 21 CFR .2) affixed to each product shall be refused entry. If your product is subject to a mandatory performance standard, you may include the accession number you reported on form FDA to indicate you have previously reported your product to the FDA.

Q39) As a foreign manufacturer, when do I need to identify a U.S. Agent?

Your U.S. Agent should be identified when you prepare your product report. Please see the requirements for U.S. Agents described in 21 CFR .25. If your products are also medical devices, please also see the information about U.S. Agents and medical device establishments at U.S. Agents on our website.

Q40) Are imported radiation-emitting electronic medical products entering the U.S. under an FDA-approved Investigational Device Exemption (IDE) also exempt from complying with mandatory performance standards under the Radiological Health program?

No, they must comply with applicable the applicable mandatory performance standards set forth in 21 CFR Parts through . Noncompliant radiation-emitting electronic medical products (such as medical x-ray, and medical laser products) cannot be legally imported, distributed or used domestically under an IDE unless they meet the applicable mandatory performance standards.

Radiation-emitting electronic medical products entering the U.S. under an FDA-approved IDE must also comply with applicable medical device regulations and electronic product regulations. In accordance with 21 CFR .1 "[S]tandards listed in this subchapter are prescribed pursuant to section 534 of Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of ) (21 U.S.C. 360kk) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety."

Therefore, although an IDE would provide exemptions from section 514 of the FD&C Act (medical device performance standards), it does not exempt manufacturers from section 534 of the FD&C Act (electronic product performance standards) or its implementing regulations, which means those regulations in 21 CFR Parts through must still be followed for radiation emitting products used in clinical studies conducted following an approved IDE. The product must comply with the applicable electronic product performance standard(s), be certified, and a completed and accurate product report must be submitted to CDRH before the product is released to the importer and clinical investigators, as required by 21 CFR .10.

Product Specific Questions

Q41) Are Light Emitting Diodes or Intense Pulsed Light Products subject to the laser regulations and reporting requirements?

Light Emitting Diodes (LEDs) and Intense Pulsed Light (IPL) products do not meet the definition of a laser.

Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250nm but less than or equal to 13,000nm or, after August 20, , at wavelengths equal to or greater than 180nm but less than or equal to 1.0x106nm primarily by the process of controlled stimulated emission as defined in 21 CFR .10(b)(19)

However, as they are radiation-emitting products, the manufacturers of and IPL products are subject to the general requirements in 21 CFR Parts through , including accidental radiation occurrence notifications and notifications of defect under 21 CFR Parts and . There are currently no applicable FDA mandatory performance standards for LEDs or IPL products. They are not subject to Product or Annual reports under 21 CFR Part .

Getting More Information

Q42) Can I contact CDRH to get guidance on the meaning of specific requirements of a performance standard or applicable regulation regarding radiation-emitting electronic products?

Yes. We want you to understand our requirements. When contacting CDRH, please try to be specific about the details of your product and what part of the standard or other regulation you are inquiring about.

Questions may be directed to or you may review the Radiation-Emitting Products web page.

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