FDA takes steps toward 510(k) reform

There has been talk of change to the FDA’s 510(k) pre market notification process for some years now. Increasing pressure from lobby groups, plus the changed climate under the current US administration has strengthened the push for reform.  In February a public meeting was held by the FDA to discuss the issues surrounding the 510(k) process and its effectiveness.  Presentations by FDA representatives highlighted FDA concerns related to the current process.

The 510(k) process involves applicants claiming substantial equivalence of a new low risk device to devices already approved. This can allow applicants to compare and liken their devices to those approved up to thirty years ago, creating cause for concern over the effectiveness and validity of the process.  FDA expressed particular concerns that manufacturers have difficulty selecting appropriate predicate devices and prefer to select the "lowest common denominator" device, or a number of devices as predicates to cover all features of the new device.  FDA are considering methods of simplifying and improving the predicate selection process, with suggested ideas including the publication of more information about approved devices, and the restriction of technically obsolete predicates.

Some higher risk devices and life sustaining or implantable devices are currently permitted to apply for approval through the 510(k) process.  A recent report by the U.S Government Accountability Office (GAO) has raised concern over this and recommended a swift issue of regulations for Class III device types currently allowed to enter the market via the 510(k) process.

In addition, FDA expressed concern about perceived limits to post-market control of 510(k) devices. Post market studies are not a requirement for 510(k) devices in the U.S and FDA has no officially explicit authority to withdraw 510(k) clearances. The non-requirement for 510(k) device manufacturers to notify the FDA of purchase, sale or transfer of 510(k) ownership also presents difficulties for the FDA in tracking post-market activities and adverse events.

The public meeting addressed these issues and more, with the program including a number of presentations by CDRH and speakers from the industry.   For a transcript of the meeting – and video files of the proceedings, click here.

US industry association Advamed responded by asserting that although there’s certainly room for improvement, the 510(k) process is essentially sound.  Advamed recently released a letter of recommendations in response to the FDA’s request for comments following the public meeting, in which many of the proposals and points raised at the meeting are echoed. The news release and letter can be viewed on the Advamed website here. 

Dramatic Slow Down in 510(k) reviews

Amongst all of this discussion of reform, recent experience shows a dramatic blow out in processing times for 510(k) reviews, with applications routinely going over the 90 day review target.  A combination of pressures for more thorough review, increase in applications and FDA’s recent relocation to White Oak have all slowed down reviews.  

Need help with applications to FDA?  In the current climate, strategy is vital. Consider your needs for pre-filing consultations and the possibility of third party assessment alternatives. Brandwood Biomedical has extensive experience of direct interactions with FDA to support 510(k), PMA and IDE reviews.  Contact us  to learn more.