US FDA Rolls Out Pilot for Simplified 510(k) Submissions
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- US FDA has launched a pilot program for streamlined 510(k) reviews using its eSubmitter software.
- Eligible premarket notification applicants are not required to submit paper copies of their premarket applications to FDA.
- FDA has set 60-day review timeframes for 510(k) applications submitted through the program, versus 90 days for standard 510(k) application routes.
The US Food and Drug Administration announced a new pilot program allowing qualified 510(k) medical device registrants to submit only electronic versions of their applications to the agency in an effort to simplify premarket reviews.
FDA’s Quality in 510(k) (Quik) Review Program pilot is intended to establish a standard form for 510(k) applications by allowing program participants to use the agency’s eSubmitter software for premarket submissions. Specifically, Quik Review Program pilot participants may utilize eSubmitter to populate fields required in 510(k) applications and save application files to USB drives, CDs or DVDs for submission to FDA. (FDA 510(k) registrants typically must submit paper as well as electronic copies of their applications.)
Through the pilot, FDA will determine whether the Quik Review Program and use of eSubmitter will yield better-organized 510(k) applications and more efficient submission reviews.
Criteria for Quik Review Program pilot participation
FDA has identified 38 product codes for moderate-risk, well-understood devices that qualify for the Quik Review Program pilot. These devices include electronic thermometers and stethoscopes, vascular clamps, mechanical wheelchairs, surgical wires, audiometers, contact lens cases and diagnostic radiology displays. (Refer to the FDA Quik Review Program guidance for the full list of eligible product codes.)
Additional criteria for participation include:
- The device is not a combination product;
- The lead FDA Center for premarket review of the device is the Center for Devices and Radiological Health (CDRH);
- The eSubmitter template “non-In Vitro Diagnostic Device—510(k)” was used to complete the submission.
Quik Review Program 510(k) preparation and submission
Using the required eSubmitter template, applicants should provide the same information necessary for a Traditional 510(k) submission; eSubmitter then formats the applicant’s submission into a ZIP file, which should be copied to a CD, DVD or USB drive.
Quik Review Program pilot participants should include a cover letter with their submissions clearly stating that they are participants in the program and are thus not required to provide paper copies of their submissions.
Registrants should keep in mind that eSubmitter may only be used for new 510(k) applications; for amendments or supplements to 510(k)s, firms should provide eCopy submissions to FDA.
FDA CDRH review policies and timeframes
FDA 510(k) applications submitted via the Quik Review Program pilot will undergo more “interactive reviews with CDRH staff; such submissions will not be subject to FDA’s Refuse to Accept (RTA) policy, and no holds or requests for additional information will be issued by agency reviewers.
“Instead, submitters of 510(k)s are expected to respond quickly to FDA requests for additional information,” states the agency.
By streamlining these review policies, FDA expects to issue final decisions for Quik Review Program pilot 510(k) submissions within 60 days as opposed to 90-day timeframe for standard premarket notification reviews.
Learn more about US FDA 510(k) processes for medical devices:
- US FDA 510(k) consulting for medical device and IVD companies
- US FDA medical device classification consulting
- Whitepaper: Early communication with US FDA
- Whitepaper: Understanding US FDA’s classification system