There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

In an effort to promote innovation while protecting the population at large, FDA has been on a path to revise the existing regulatory pathway surrounding the 510(k) process for medical devices for several years. This continues to be an area of many questions and considerations. In fact, we’ve devoted a whitepaper to these issues to help researchers understand the 510(k). Recently FDA released a Draft Guidance on the eCopy Program for Medical Device Submissions. While this system is currently voluntary, the draft guidance gives industry an idea of what might be in store for device submissions.

It wasn’t too long ago that new recommendations for improving the 510(k) medical device review processes were published with the goal of installing a pre-review assessment that would check applications and reject submissions dibbed incomplete.  FDA took steps forward with this plan and released the FDA Draft Guidance: Refuse to Accept Policy for 510(k)s (RTA).

 “One reason I think it’s going to change is we’re starting to see change already.” This statement was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, “substantially equivalent”, to a marketed device. For devices that are low to moderate risk but are found to be “not substantially equivalent” to a predicate device, the de novo classification process provides a possible route to market.

Currently 510(k) applications are used to approve investigational devices that are largely equivalent to devices that the FDA has already approved. According to an article in MassDevice, The FDA issued new recommendations for improving the 510(k) medical device review process by installing a pre-review assessment that would check applications and reject submissions dubbed incomplete. The details can be found in FDA Draft Guidance: Refuse to Accept (RTA) Policy for 510(k)s.

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

Discussion on the FDA’s 510(k) program remains a very popular topic.  According to an article in MD+DI, industry groups are urging major changes on the FDA’s draft on evaluating substantial equivalence in 510(k)s.  Not surprisingly, Public Citizens is asking the agency to delay the guidance because they feel it’s overly permissive.

The new 510(k) guidelines released by the FDA aim to provide transparency and predictability for companies that are seeking lower-risk device approval through the 510(k) pathway.  Since the initial draft guidance was released, critics have argued that these proposed changes could negatively impact industry, raising the R&D costs to bring a non-significant risk device to market and potentially pushing jobs out of the US as companies strategically look for less cumbersome routes of approval. With the release of the official less cumbersome guidelines, new critics have emerged, stating that the American public ends up the big loser due to the concessions that the FDA made, purportedly as a result of pressures from Congress and industry.

A new pilot program that started this month may bring about noticeable changes in 510(k) reviews. Starting in April 2012 and running until October 2012 the FDA is testing The Triage Pilot Program. According to the website, the objective is to reduce the review time of Traditional 510(k) applications that are of good quality as incentive to sponsors to submit such applications.