May 2011 Volume 7 Number 9

Premarket Notification and the 21 st Century Regulatory System: Safety, Efficacy – Economy?

By Sean W. Develin, DevRose Systems Ltd, West Chester, PA


With the specter of the United States economy still looming over his administration, President Obama began 2011 by signing an executive order requiring that “federal agencies ensure that regulations protect our safety, health and environment while promoting economic growth.”1 An early example of this particularly difficult balancing act, cited by the President in his January 18th Wall Street Journal Op-Ed article, is the revised 510(k) Premarket Notification process for new medical devices.2 The 510(k) process, named after the section of the Federal Food, Drug, and Cosmetic Act from which it originates, is the most commonly used pathway for regulatory approval of new medical devices in the U.S.3

The overhaul of the 510(k) process was initiated under the Obama administration in 2009 and, in conjunction with the Executive Order and Op-Ed article, its implementation plan was announced in late January.4 There is no single motive for the review of the 510(k) program, other than, perhaps, its age. According to the Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), the Premarket Notification process, which is 30 years old, clears some 3,000 new devices annually.5 In recent years, increasing concerns regarding its effectiveness have been raised by industry, healthcare practitioners, trial lawyers, and the public.

In response to these concerns, CDRH created both a Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making and charged them with evaluating the existing process. Preliminary reports of both entities were released in August 2010. 6 Having received and considered public comment, CDRH plans to implement twenty-five Working Group and Task Force recommendations in the current calendar year – including ones for which there is significant industry concern, as addressed below. 7 CDRH describes its challenge as the need to balance innovation and public safety, which clearly reflects its alignment with the President's mandate. Acknowledging the need to balance these two, often competing interests is laudable. The question remains: can it be done?


This balancing act is not new to the FDA. There are legitimate reasons for the FDA to support innovation that do not conflict with its mission of protecting public health. Innovative technologies can improve patient safety. To unnecessarily hinder their creation and adoption would prevent the public from accessing potentially beneficial care and treatment.

The conflicts between safety and innovation, however, have become particularly visible now that it is time for FDA to act on the reports.

CDRH received seventy-six comments reflecting the concerns and input of diverse, impacted groups. It should be noted that half of the recommendations – twenty-eight out of a total of fifty-five – received “broad support” for their individual content.8 Where there is opposition, however, the concerns arise for different reasons, and seek to pull FDA in different directions.

Comments from industry fell on both sides of the scales. While some supported safer device design, others o bjected to additional regulation for reasons ranging from burden and industrial espionage to freedom of commercial speech.9 Trial lawyers, who often serve as vital advocates for the public health, were among those in support of expanding CDRH authority to rescind 510(k) clearance, while the medical device industry remains opposed to such authority.10


The details of the recommendations to be implemented this year are published in the Plan of Action for Implementation of 510(k) and Science Recommendations released by CDRH on January 19, 2011. 11 Guidance will be a key mechanism for implementing the Working Group and Task Force recommendations, with no less than eight draft documents scheduled to be completed by the end of the year. Proposed guidances include, but are not limited to:

  • Guidance clarifying types of modifications that require a new 510(k) – this is a particularly critical area, as some in industry prefer to downplay the impact of modifications in order to avoid additional filings and regulatory scrutiny.12
  • Guidance on when devices are no longer available as “predicates” due to safety reasons. Predicates are substantially similar devices already legally marketed in the U.S. that are used for reference in 510(k) filings.
  • Guidance for the creation of a “Class IIb” - including requirements for submission of clinical data.13
  • Device-specific guidance requiring manufacturers to provide regular updates regarding device modifications; and
  • Device-specific guidance requiring 510(k) submitters to identify all scientific safety and efficacy data known to the submitter. This was originally recommended as a modification of 21 CFR 807.87, but will be implemented through guidance first. 14

Beyond guidance, select recommendations, as detailed in CDRH’s Plan of Action for Implementation of 510(k) and Science Recommendations, will be referred to the Institute of Medicine (IOM), the nonprofit health arm of the National Academy of Sciences. The IOM will evaluate the recommendations as part of its ongoing, independent consensus study of the 510(k) process. The IOM is expected to release its report in mid-2011. 15 Any feedback it provides will be taken into consideration by CDRH, but will not necessarily be implemented.

Concerns over two recommendations – Device Photographs and an online Labeling Repository – were the subject of a public meeting at FDA’s White Oak, Maryland campus, on April 7, 2011, as addressed below. 16

Points of Contention: Device Photographs and Labeling Repository

In his Wall Street Journal article, President Obama identified the need to use “disclosure as a tool to inform consumers of their choices, rather than restricting those choices.”17 In recent years, one of the FDA's preferred mechanisms for disclosure has become the public database, which is at the heart of the two issues discussed at the meeting.

The 510(k) Working Group recommendations call for CDRH to create a public database that will contain a photograph of each cleared device.18 This recommendation raised immediate alarm from the medical device industry. FDA emphasizes that proprietary information would not be made available, but just what is and is not proprietary information is in contention, given the relationship of form and function and the extent they can be revealed in photographs.19

The second recommendation subject to the public meeting pertained to labeling. Specifically, the Task Force recommended that CDRH “take steps to improve medical device labeling” and “develop an online labeling repository to allow the public to easily access this information.” 20 The FDA has already implemented a similar database for drug labeling. Industry objections included concerns that proprietary information would be disclosed, and that labeling language is often addressed to doctors and healthcare providers and therefore would be of little value in patient decisions due to its technical nature. 21 CDRH does not seem to give these arguments weight, and points out that companies often publish their labeling on their own websites, and experience with the drug database has, FDA contends, demonstrated a public health benefit for both practitioners and patients. 22

The public meeting took a feedback gathering approach, with FDA delivering a series of presentations explaining its thinking on these matters, followed by solicitation of oral and written comments from attendees. FDA has also opened the issues for public input, with comments due to FDA by May 10, 2011.23


CDRH has mapped the path forward, and the overhaul of the 30-year old 510(k) program is underway. Now industry and other interested parties must wait and watch for the results of the public meeting, the findings of the IOM report, and the content of the draft guidances. Whether the revised Premarket Notification process strikes the balance President Obama desires won’t ultimately be known until the final recommendations are implemented and industry begins operating under them.

1 Barack Obama, Toward a 21-st Century Regulatory System , WALL ST. J., Jan. 18, 2011, (last visited Feb. 18, 2011). The Executive Order referenced is Exec. Order No. 13,563, 76 F.R. 3821 (Jan. 21, 2011).
2 Id.
3 U.S. Food and Drug Administration, A Letter from the Center Director (available at
4 Obama, supra note 1.
5 A Letter from the Center Director, supra note 3.
6 The Working Group’s mandate pertains specifically to the 510(k) process. The Task Force on the Utilization of Science in Regulatory Decision Making has a broader, ongoing mandate. See U.S. Food and Drug Administration, 510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps, p. 1 (available at
7 There were 55 total recommendations. The disposition of the recommendations not chosen for implementation in 2011 is solely at FDA’s discretion. FDA may implement them in future years or choose to take no further action. Id ., at 3.
8 The recommendations chosen for implementation are those that FDA selected, and include ones receiving broad support and others for which there was opposition or concern. Id ., at 1.
9 Id., at 11.
10 Industry fears include loss of revenue and product liability. See id ., at 14.
11 U.S. Food and Drug Administration, Plan of Action for Implementation of 510(k) and Science Recommendations, (available at
12 510(k) and Science Report Recommendations at 15.
13 Class IIb, as proposed by the 510(k) Working Group, would be an administrative subset of higher-risk class II devices that require clinical and manufacturing information and possible postmarket evaluation. FDA has not determined what devices would fall under a “class IIb” subset but has suggested that such devices would include life-sustaining devices, and/or life-supporting devices. See id ., at 17.
14 21 CFR 807.87 details the information required in a premarket notification submission. The regulation does not currently require the identification of all scientific safety and efficacy data known to the submitter. See id .
15 Institute of Medicine of the National Academies website, (last visited Feb. 18, 2011).

Plan of Action for Implementation of 510(k) and Science Recommendations at 4-5.


Obama, supra note 1.


510(k) and Science Report Recommendations at 20.

19 Industry specifically wants to restrict access to any images that could be used to reverse-engineer a competitor device. Id .
20 Id., at 11.
21 Id.


23 See

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