medical devices

510(k) Process Comes Under Renewed Scrutiny by Legislators, Awaiting FDA Response as Proposed Legislation Remains Stagnant

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Ashley-Zborowsky.jpg Several months ago, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) wrote a letter to Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration, calling for an overhaul of the 510(k) pre-market notification database. The legislators cite reports of defective medical devices cleared via the 510(k) process in recent years, such as the DePuy® artificial hip, that have caused “grievous[] and irrevocabl[e]” harm to patients.

The issue? Most devices subject to premarket review are cleared through FDA’s 510(k) process which provides expedited approval for products that are deemed “substantially equivalent” to an existing predicate device. While the 510(k) process allows patients earlier access to devices, the system is inherently flawed. Referred to as “predicate creep,” the 510(k) process clears generations of devices–none of which have been subject to the exacting scrutiny of pre-market approval (the PMA process). As Markey and Merkley cite in their letter to Shuren, many predicate devices upon which new products rely for 510(k) clearance themselves have been recalled by manufacturers due to “fundamental design flaw[s].”

The legislators asked Shuren and the FDA to retrospectively update the 510(k) database to clearly indicate devices recalled for serious design flaws that could adversely affect safety or effectiveness. The letter also asked FDA, among other things, to develop a mechanism for identifying certain 510(k) entries to “reflect instances where a device’s clearance traces back to a predicate recalled for a serious design flaw adversely impacting its safety, even if the original problematic device is not the immediate predicate.” For additional in-depth discussion of issues surrounding the existing 510(k) process and substantial equivalence, including product liability considerations see “Rethinking Lohr: Does ‘SE’ Mean Safe and Effective, Substantially Equivalent, or Both?

After the Institute of Medicine released its highly controversial report on the current 510(k) process last year (stating that the process is flawed and recommending a new pre- and post-market regulatory framework to provide a reasonable assurance of safety and efficacy), the issue of device safety has been omnipresent in policy debates surrounding related concerns of access and innovation. For a critique of the IOM report and a summary of its findings, see “A Failure to Comply: An Initial Assessment of Gaps in IM’s Medical Device Study Committee” and “Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.” In January, Representative Markey and others introduced H.R. 3847, coined The SOUND Devices (Safety of Untested and New Devices) Act of 2012. The bill proposes to amend the Federal Food, Drug and Cosmetic Act to allow the FDA to reject a claim of substantial equivalence for a device whose predicate has been “recalled, corrected or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety . . . .” in light of these concerns.

In testimony given to the House Committee on Energy and Commerce on device user fees back in February, Shuren discussed strategic priorities for the 510(k) process, including developing methods and procedures for the systematic analysis and use of medical device recall information by September 30, 2012. However, now that the Medical Device User Fee Amendments (MDUFA III) have been enacted, reauthorizing device user fees through fiscal year 2017, perhaps the FDA and CRDH will finally be able to make progress in revamping the 510(k) system. As Shuren noted in his testimony, “[w]hile it is true that providing more user fee resources alone won’t solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to, several of these problems. Adequate and stable funding is one key component to our and industry’s success in bringing safe and effective devices to market quickly and efficiently.”

Currently, the 510(k) process remains unchanged. Though legislators requested an official response no later than September 19, 2012, the FDA and Shuren have yet to release a statement (at least publicly) regarding these concerns. Additionally, it is unclear whether CDRH has made any headway in meeting its target goals. As we approach the end of 2012, 510(k) still leaves much to be desired–the highly anticipated changes to the pre-market clearance process are provisional at best. It seems as though Markey isn’t having much luck in Congress either. H.R. 3847 is awaiting approval from the House Committee on Energy and Commerce (and has been since shortly after its introduction). According to, an online bill tracking website, the bill has only an estimated three percent change of being enacted.

FDA Approvals are a Matter of Life and Death

mjlst-logo-button.pngMJLST faculty editor-in-chief Ralph Hall and Andrew Von Eschenbach, former commissioner of the U.S. Food and Drug Administration (2005-2009), wrote an opinion piece in the June 18 Wall Street Journal on ways to move medical devices more quickly into the hands of health care practitioners. They cite the example of the American-made SAPIEN Transcatheter Heart Valve (pictured right) that was available to patients in Europe four years before those in the United States. Read “FDA Approvals Are a Matter of Life and Death” (WSJ). (NOTE: the WSJ article can be viewed in full by using Google to search “FDA Approvals Are a Matter of Life and Death” and then clicking the first link to WSJ in the results.).

In a related article in MJLST issue 13.1, Professor Hall and Eva Stensvad outlined problems with the 510(k) medical device clearance process and argued that while the Institute of Medicine (IOM) is generally an invaluable policy resource, invaluable policy resource, its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process is not fairly balanced and unable to fairly and accurately perform its duties. Read: Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.