On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

Third Party Recognition Boards (TPRs) provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid 510(k) decisions.  Recently FDA issued draft guidance, “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program.” TPRs are intended to enable FDA to use its resources for reviewing higher-risk and complex devices and also hopefully increase the review times for the medical device industry.

Many researchers are proposing a reclassification of all hip joint metal-on-metal hips as there may exist a regulatory loop-hole allowing dangerous devices to reach patients. FDA proposed a new rule that would require these devices to submit a Premarket Approval Application (PMA) which were being accepted through the 510(k) process.

This is a question that FDA is asking the public. Recently on Federal Register, the FDA announced an opportunity for the public to comment as part of an assessment process of the medical device review/submissions.  This opportunity stems from the MDUFA Commitment Letter, where FDA has a section describing the assessment of review process management to meet certain performance goals agreed to by industry and FDA.

For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry? According to a new report on FDA’s website, the plan implemented in January 2011 aimed to modernize and improve the premarket review of medical devices is working. This development seems promising as the speed and predictability of medical device review has improved for the first time in almost a decade- according to FDA’s report.

In order to better understand the CDRH’s review of submissions that were found to be Not Substantially Equivalent (NSE), FDA published on its website the initial results of 510(k) audit as part of the Action Plan implemented in January 2011. The determination of NSE not only is an inefficient use of FDA’s time and resources, but can also be a costly delay for industry. With this information and analysis now available, the goal is for sponsors to understand the reasons the NSE determination resulted, as well add some clarification to the process.

A recent survey of almost 200 med-tech executives measured the perceptions of the 510(k) pathway, FDA’s performance, and FDA’s consistency. While FDA continues to try and clarify the pathway for approval, there continues to be much controversy and confusion of the direction of the program. This is in stark contrast to FDA’s goal of 510(k) which is to provide predictability for companies seeking lower-risk device approval. So, what did the recent survey show?

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).