FDA Pulse Check: October 2017

As the year begins to wrap up, FDA is finalizing several pieces of guidance and initiatives as it heads into FY 2018. Here are some previews and highlights for October: National Cybersecurity Month

National Cybersecurity Month

October is National Cybersecurity Month—a topic which FDA has been increasingly vocal about within the last few years as more medical devices become interconnected. Incidents such as the WannaCry ransomware attack and the discovery of hackable insulin pumps have caused organizations and regulatory bodies alike to evaluate the cyber safety of current devices and potential impacts of failure on patient safety.

FDA has multiple resources available. Their myth vs. fact sheet details what FDA’s role in cybersecurity for medical devices is, and their premarket and postmarket cybersecurity guidelines are readily available for review. As well, they recommend general best practices for cyber safety from the Department of Homeland Security. With all of these available resources, now is a good time for your organization to make sure your devices are implementing the most robust cybersecurity possible.

Guidance on User Fees and Refunds

FDA has updated its guidance on user fees and refunds for 510(k)s and Biologics License Applications. These updates were issued following the enactment of the Medical Device User Fee Amendments of 2017—the fourth reauthorization of this legislation (MDUFA IV). These new guidance documents supersede the 2013 updates.

Each updated guidance document contains updated information about user fees and refund procedures for both types of submissions. Organizations can also learn more about the updates and other MDUFA IV updates on the CDRH Learn page.

Updated Guidance on the Pre-Submission Program

Other guidance updated as a result of MDUFA IV includes FDA’s pre-submission program. The “Pre-Sub” program, as it is also known, allows organizations to obtain feedback from FDA about their ongoing device submission. This process helps organizations understand whether they are on track to satisfy reviewers during the official premarket submission process and where potential gaps may lie in their existing product development process.

The updated Pre-Sub guidance provides an overview about the available FDA mechanisms to request FDA feedback. In addition, it details the steps of the Pre-Sub process, from submission to conducting review meetings. FDA has also updated its timeline for Pre-Sub reviews, their requirements for submissions, and whether specific documentation is necessary (based on device type).

MDUFA IV Goals for the FDA Review Clock

MDUFA IV has been a big catalyst for CDRH’s current and future regulatory activities. Among other things, the legislation forced an update on all guidance for premarket submission review timelines. FDA forecasts an overall reduction in review times across submissions between 2018 to 2022, as much as up to 13 percent.

These updated guidance documents detail the actions that both FDA and the submitter can undertake during each review process. Understanding what these actions are and what the review clock looks like can help organizations understand and prepare for the submission process more thoroughly. Among the submissions affected are 510(k)s, De Novo Classification Requests, and Premarket Approval Applications.

November’s FDA Forecast

With MDUFA IV now active, the FDA will likely begin working on their performance goals and procedures moving into FY2018 and beyond. They will also begin aligning MDUFA IV with changes passed into law with the 21st Century Cures Act.

We can also expect that FDA may start looking into infrastructure expansion within CDRH to help them better assess quality management, expand their scientific and regulatory review capacities, update their IT infrastructure, and so on. These changes are anticipated to have an impact on making the submission process more streamlined and agile within these next few fiscal years.

There are some scheduled actions and events on FDA’s calendar for November to be aware of. First, they are holding public hearings and request for comments on potential approaches for devices referencing drugs (DRDs). Organizations developing DRDs are increasingly seeking marketing authorization for use with already approved drugs, and FDA is looking for feedback on the best ways to address their presence on the market. Second, FDA is hosting an educational workshop entitled “Partners in Progress: Cancer Patient Advocates and FDA.” The workshop provides basic training to better clarify the role of FDA and cancer patient advocates in oncology product development.

Overall, FDA looks to be increasing their regulatory activity in the final few months of this year. We can anticipate a busy end of the year and hints at their priorities for FY 2018.