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Assessing the Proposed Changes to the US FDA's 510(k) Programme
by Karen M. Becker, PhD, Founder and Chief Executive Officer of Becker & Associates Consulting, Inc.

Nov 06, 2010 | Free Downloads | email | Print

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Note: This article originally appeared in the September-October issue of Regulatory Affairs Medtech, and was published online at on September 8, 2010.

The paradigm applied for providing reasonable assurance that every medical device marketed in the US is safe and effective is the most stringent in the world. In accordance with current applicable law, regulations, guidance and policy, these critical healthcare products are required to be designed, tested, manufactured, cleared and marketed in compliance with a detailed series of rigorous requirements and standards.

The Food and Drug Administration has considerable enforcement authority under the current paradigm and vigorously pursues violations of the law and applicable regulations. Despite a chronic lack of resources, the agency clears more than 4,000 Class I and II devices under the 510(k) pre-market notification procedure every year, while also regulating with similar rigour various other products that comprise approximately 25 percent of the gross domestic product in the US (drugs, foods, cosmetics and veterinary drugs).

The concern of looming "over-regulation" has never been greater.

The 510(k) process has nonetheless come under criticism in recent years, with some constituencies (including the FDA) proposing fundamental changes to the regulatory paradigm.

The Existing Paradigm

Medical devices authorised for marketing in the US have been regulated by law since 1976 based on classification of the risk associated with each type of device and the extent of control required to ensure that products coming to the market are safe and effective. As is well-known to all who work in the medical technology field, the vast majority of these products are regulated as either Class I or Class II devices, which can be legally marketed only if all applicable requirements are met following review and clearance by the FDA via a 510(k) pre-market notification. The highest-risk products, Class III devices, require submission of a pre-market approval application to the FDA prior to marketing. Regardless of their classification, all medical devices sold in the US must be both safe and effective.

The system for medical devices, as it now stands, was specifically designed to provide not only safe and effective products, but to ensure that scientific innovation, which contributes to the public health, is not stifled by overregulation. "Over-regulation" is a term that arises in the US every time a new amendment to the existing law is under consideration (such occasions having been numerous) since the 28 May 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act became law. This phrase is short-hand for the often reasonable concern that changes to the existing paradigm will introduce even greater regulatory burdens, which translate to higher costs to maintain compliance and thereby result in fewer innovative products reaching patients in the US.

Two Formal Reviews

Never in the history of medical device regulation by the FDA has the concern of looming "over-regulation" been greater. Various factors have converged to prompt two formal reviews of the process by which FDA regulates medical devices. The FDA established a 510(k) working group in September 2009 as part of a two-pronged assessment of the scientific and regulatory components of the 510(k) process. In addition, an independent review of the 510(k) process is under way by the Institute of Medicine, which is part of the National Academy of Sciences, a nongovernmental organisation.

As is reported elsewhere in this issue, the FDA has issued its preliminary reports and recommendations for consideration and public comment. The report and recommendations from the IOM will not be completed until September 2011. Industry, patients, and healthcare providers and payers are currently commenting on the more than 70 recommendations suggested by the FDA working group1-4. Because many of these recommendations require changes to the law, there is no expectation that significant change will occur until after the IOM report is issued. (The FDA has already implemented one recommendation, namely, to establish a new Center Science Council).

FDA Internal Review Findings

The FDA conducted its internal reviews with commendable objectivity and clarity. In fact, the problems that FDA personnel face mirror those faced by industry. It is universally agreed that confusion has developed regarding how key requirements of the law and regulations are defined, that inconsistency in how the review process is carried out has increased, and that there is a lack of predictability regarding the type and extent of data required by the FDA to clear a 510(k) pre-market notification.

Among the most telling observations by the FDA is that, no matter how hard they work, FDA staff is being held back by the lack of a state-of-the-art infrastructure and access to scientific expertise commensurate with the rapidly emerging technologies that they are expected to regulate.

The agency also notes, from its own survey data, that a surprising number of managers and reviewers are not able to correctly answer fundamental questions regarding the present regulatory scheme. For example, 40% of reviewers were unaware that a product must have the same intended use as a predicate, by law, as a threshold requirement for the determination of substantial equivalence. More extensive training, as well as the preparation of additional guidance documents, clarification of definitions and design of templates for submissions, are all reasonable suggestions by the FDA to remediate some of the systemic problems that currently pose difficulties to both FDA and industry.

Some 40% of FDA reviewers do not know the most basic requirement that must be met for them to clear a 510(k).

Does the fundamental legal and regulatory paradigm for the clearance of Class I and Class II medical devices need to be changed? In considering whether or not fundamental change is needed, it seems logical to consider - first and foremost - patient safety. Does the current system prevent unsafe products from reaching the market; and does the FDA, at present, have sufficient authority to enforce the requirements needed to mitigate that risk, consistent with its mandate to protect the public health?

Over the years, one can find examples of Class II products cleared, the safety of which have subsequently been questioned. However, if one examines the FDA enforcement reports for medical devices, a quantitative analysis does not indicate any systemic failure on the part of the agency to prevent unsafe products from reaching, or remaining on, the market. In fact, the data indicate just the opposite.

The FDA has, and continues to, prevent unsafe Class I and Class II products from reaching the US market, via both the review process and enforcement actions. In 2008, for example (the most recent year for which there is complete data), the FDA conducted over 2,500 inspections and issued over 150 warning letters. Only one injunction was issued, there were no seizures and only 14 Class I recalls occurred. (The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.)

Of the 14 recalls, many were for Class II devices, but most were for limited lots of legally marketed products. Considering that millions of different medical devices are in use every day, the incidence of serious adverse events attributed to, or associated with, Class I and Class II devices remains rare.

The Risk of Unintended Consequences

If changes to the current paradigm are to be made without introducing unnecessary burdens on the FDA and industry, it is reasonable to consider only those proposed changes that will enhance the ability of the FDA to both promote and protect the public health. For example, does the FDA really need to review every modification to a device, or just those which may have a significant impact on the device's safety or effectiveness? The FDA already requires and enforces conformity to very comprehensive quality system regulations, which include design controls. Does the FDA really need to "verify" the content of every 510(k) summary, when US law requires all submissions to the agency to be truthful and accurate, and violations are extraordinarily rare? Will it significantly advance the public health if confidential, proprietary and/or trade secret information from cleared 510(k) submissions is made public?

Despite the extensive external and internal scrutiny, it is important not to overlook that the fundamental basis of the 510(k) programme is well-designed, and to consider carefully the intended (and unintended) consequences of change.

Around this time next year, Congress will be considering a plethora of recommendations for change from all stakeholders. It is fairly certain that we will see statutory changes in 2012.

One hopes that these changes will include the provision of additional resources for the FDA and that the changes add value to the current system without eliminating the original intent of Congress to establish a process that provides access to safe and effective devices while encouraging innovation.

The author wishes to acknowledge the contributions to this commentary by Kathryn T Cole, research associate, Becker & Associates Consulting, Inc.


1. FDA, Preliminary Internal Evaluation: Volume I, 510(k) Working Group Preliminary Report and Recommendations, 3 August 2010,

2. FDA, Preliminary Internal Evaluation: Volume II, Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations, 3 August 2010, downloads/AboutFDA/CentersOffices/CDRH/ CDRHReports/UCM220783.pdf

3. US FDA's 510(k) group suggests device clearance process overhaul, RAJ Devices online, 5 August 2010

4. Uneasy feeling for US industry as detail emerges of 510(k) overhaul, RAJ Devices online, 6 August 2010

Karen M. Becker, PhD, is founder and Chief Executive Officer of Becker & Associates Consulting, Inc. (BECKER CONSULTING), located in Washington, DC. The firm is a leader in providing strategic scientific consulting services to healthcare companies, counsel, and investors. Assignments for clients are typically focused on resolving complex scientific and regulatory matters for FDA regulated products (drugs, devices, cosmetics, and foods). Dr. Becker and the senior leaders of the team have managed successful engagements in this high-risk high-reward environment for over 20 years.

The core competencies of BECKER CONSULTING are:

  • FDA Regulation of Medical Devices, Pharmaceuticals, Cosmetics, & Foods
  • Healthcare Economics and Research
  • Litigation Support and Expert Testimony

Services include due diligence for acquisitions, regulatory and reimbursement strategies, clinical trial design and analysis, and FDA negotiations, appeals, and submissions. Successful resolution of client matters is achieved through application of sound science, innovative approaches, and a commitment to outstanding quality and service (see

Dr. Becker is recognized for her ability to manage complex medical device and drug approvals for innovative healthcare products. Therapeutic areas with which she has direct experience over 20 years include implanted devices (neurologic, cardiovascular, soft tissue, orthopedic, gynecologic), wound care products, oncolytics, anti-infectives, cardiovascular drugs, dermatologics, anti-inflammatory drugs, analgesics, cosmetics, and drug delivery systems. Recent assignments include managing the successful first appeal to the FDA Medical Devices Dispute Resolution Panel, which resulted in a unanimous decision in favor of the sponsor, and reversal of a Blue Cross/Blue Shield TEC decision on treatment for prostate cancer. Dr. Becker is the editor of the textbook "Clinical Trials of Medical Devices. Principles and Practices" (Humana Press,1998; 2004 with J. Whyte), and has written extensively on the regulation of FDA products. She teaches management consulting as an adjunct professor at Georgetown University McDonough School of Business.

Dr. Becker received a BS in Biological Chemistry (University of Maryland) and a PhD in Pharmacology (University of North Carolina School of Medicine).

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