FDA Pre-Sub Program Means Earlier Engagement

In short

Approaching the regulator for guidance early in the submission process is not an entirely new concept and has been mooted as a likely formal step in forthcoming European medical device regulatory reforms. In what looks like another gradual coalescence of views, FDA has seemingly got the same idea as it is issuing guidelines under which it will give medical device makers feedback before they submit a product- or research-specific application.


Regulatory control over medical devices has never been higher profile, and is rarely far from our pages in the wake of the all-metal hip problem, troublesome ICD leads, non-conforming breast implants to name a few. Regulators both side of the pond are talking quite tough about the future regulatory burden and their views seem to be increasingly on the same page. We’ve already heard the calls for a European PMA for example and a recent UK parliamentary select committee on device regulation heard plenty from Jacqueline Minor, Director of Consumer Affairs at the EU commission about other ideas including that of earlier engagement between companies and regulators. Whether this is an attempt to streamline the latter stages of the process or ensure that regulators get inside the tent earlier and in so doing contribute to a better outcome, either or both consequences would be welcome improvements.

Across the pond then FDA’s new initiative, called the pre-submission program (“pre-sub”) expands on the existing pre-Investigational Device Exemption (pre-IDE) program, which does allow medical device companies to obtain feedback prior to the formal application process, but is intended to foster innovation by helping researchers identify regulatory requirements earlier in the development stage.

The draft guidelines are part of the FDA’s commitment in the newly approved user fees legislation (MDUFA), which is designed to enhance the transparency and predictability of the CDRH’s pre-market notification 510(k) program.

According to the agency, the guidelines help advise medical device companies improve the effectiveness of pre-market submissions by describing when developers will benefit from FDA feedback and explain how best to engage the agency in informal meetings to discuss new technology or planned submissions.

Federal officials said they will now seek public comment on the draft before final approval.

FDA comments

“No matter the regulatory pathway, FDA’s early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process,” Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH), noted.

“FDA feedback to device developers early in the process can ultimately lead to more timely regulatory actions and innovative new devices for patients,” added Dr. Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety.