The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

Posted 15 October 2014 | By Alexander Gaffney, RAC

FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is once again expanding an electronic submission pilot program meant to make it substantially easier for companies to create and submit a 510(k) premarket submission to the agency.


As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a hard copy or a compact disk."

Think of it like TurboTax for 510(k)s. The "guided interface," which FDA officials have compared to the tax preparation software, will have several features to "ensure appropriate regulatory submission standards and recommendations are met or considered," FDA said in a Federal Registernotice announcing the program.

The net benefit to both FDA and industry should be more compliant 510(k) submissions and less time-consuming application submissions and reviews.

Limited Roll-Out

When the program launched, FDA said it was going to start small, and then expand in scope. In the initial months of the eSubmissions pilot, FDA rolled out the program only to manufacturers of a subset of cardiovascular devices.

Then, in late August 2014, FDA told Focus it would be expanding the pilot program to manufacturers of all cardiovascular devices regulated by CDRH's Office of Device Evaluation. At the time, Nels Anderson, an ODE biomedical engineer who is coordinating the pilot program, told Focus eight companies were already involved in the pilot, and more had expressed interest.

Initial feedback from companies had been "positive," Anderson said, with companies finding the process "much faster" than the traditional applications process and allowing for same-day submissions of filing amendments.

Wider Pilot Project

Now FDA is rolling out the program to even more participants, the agency announced last week.

In addition to cardiovascular devices, FDA will now be allowing any devices regulated by ODE's Division of Neurological and Physical Medicine Devices, Division of Orthopedic Devices, or the Division of Surgical Devices to participate in the program.

The program has also been extended for several more months, and is now set to expire at the end of December 2014.

The agency has also created a new webpage for the eSubmission Pilot program to answer common industry questions.


FDA eSubmissions Pilot Program

Regulatory Focus newsletters

All the biggest regulatory news and happenings.