Assessing the Proposed Changes to the US FDA's 510(k) Programme

For Medical Device

Karen Becker

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, guidanceand 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 oftenreasonable 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 reachingpatients 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 thescientific 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 withcommendable objectivity and clarity. In fact, theproblems that FDA personnel face mirrorthose faced by industry. It is universally agreedthat confusion has developed regarding howkey requirements of the law and regulationsare defined, that inconsistency in how the review process is carried out has increased,and that there is a lack of predictabilityregarding the type and extent of data requiredby the FDA to clear a 510(k) pre-marketnotification.

Among the most telling observations by theFDA is that, no matter how hard they work,FDA staff is being held back by the lack of astate-of-the-art infrastructure and access toscientific expertise commensurate with therapidly emerging technologies that they areexpected to regulate.

The agency also notes, from its own surveydata, that a surprising number of managers andreviewers are not able to correctly answerfundamental questions regarding the presentregulatory scheme. For example, 40% ofreviewers were unaware that a product musthave the same intended use as a predicate, bylaw, as a threshold requirement for thedetermination of substantial equivalence. Moreextensive training, as well as the preparation ofadditional guidance documents, clarification ofdefinitions and design of templates forsubmissions, are all reasonable suggestions bythe FDA to remediate some of the systemicproblems that currently pose difficulties toboth 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 regulatoryparadigm for the clearance of Class I andClass II medical devices need to be changed?In considering whether or not fundamentalchange is needed, it seems logical to consider- first and foremost - patient safety. Does thecurrent system prevent unsafe products fromreaching the market; and does the FDA, atpresent, have sufficient authority to enforcethe requirements needed to mitigate that risk,consistent with its mandate to protect thepublic health?

Over the years, one can find examples ofClass II products cleared, the safety of whichhave subsequently been questioned. However,if one examines the FDA enforcement reportsfor medical devices, a quantitative analysis doesnot indicate any systemic failure on the part ofthe agency to prevent unsafe products fromreaching, or remaining on, the market. In fact,the data indicate just the opposite.

The FDA has, and continues to, preventunsafe Class I and Class II products fromreaching the US market, via both the reviewprocess and enforcement actions. In 2008, forexample (the most recent year for whichthere is complete data), the FDA conductedover 2,500 inspections and issued over 150warning letters. Only one injunction wasissued, there were no seizures and only 14Class I recalls occurred. (The FDA defines aClass I recall as a situation in which there is areasonable probability that the use of, orexposure to, a violative product will causeserious adverse health consequences ordeath.)

Of the 14 recalls, many were forClass II devices, but most were for limited lotsof legally marketed products. Considering thatmillions of different medical devices are in useevery day, the incidence of serious adverseevents attributed to, or associated with, Class Iand Class II devices remains rare.

The Risk of Unintended Consequences

If changes to the current paradigm are to bemade without introducing unnecessaryburdens on the FDA and industry, it isreasonable to consider only those proposedchanges that will enhance the ability of theFDA to both promote and protect the public health. For example, does the FDA reallyneed to review every modification to adevice, or just those which may have asignificant impact on the device's safety oreffectiveness? The FDA already requires andenforces conformity to very comprehensivequality system regulations, which includedesign controls. Does the FDA really need to"verify" the content of every 510(k) summary,when US law requires all submissions to theagency to be truthful and accurate, andviolations are extraordinarily rare? Will itsignificantly advance the public health ifconfidential, proprietary and/or trade secretinformation from cleared 510(k) submissionsis made public?

Despite the extensive external and internalscrutiny, it is important not to overlook thatthe fundamental basis of the 510(k)programme is well-designed, and to considercarefully the intended (and unintended)consequences of change.

Around this time next year, Congress will beconsidering a plethora of recommendationsfor change from all stakeholders. It is fairlycertain that we will see statutory changes in2012.

One hopes that these changes will includethe provision of additional resources for theFDA and that the changes add value to the current system without eliminating the originalintent of Congress to establish a process thatprovides access to safe and effective deviceswhile encouraging innovation.

The author wishes to acknowledge thecontributions to this commentary by Kathryn TCole, research associate, Becker & AssociatesConsulting, 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, TaskForce on the Utilization of Science in RegulatoryDecision Making Preliminary Report andRecommendations, 3 August 2010,

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

4. Uneasy feeling for US industry as detail emerges of510(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).