FDA Invites Participation In Pilot 510(k) eSubmission Program
By Chuck Seegert, Ph.D.
A pilot program for the electronic submission of 510(k) documents is being expanded after a successful initial test period. The online process has been likened to commercial tax software and promises to increase ease of use for companies that are submitting a 510(k) application.
A new electronic submissions (eSubmission) process may go a long way toward improving the 510(k) submission process, according to a recent announcement from the FDA in the Federal Register. While the FDA has been moving toward electronic submissions since 1999, the new approach will provide even greater harmony between the agency and parties performing submissions.
During the pilot study, all 510(k) submissions will have their initial review waived, which is a change that the FDA expects to become a permanent part of the process moving forward, according to the announcement. The new submission software is designed to ensure that each 510(k) is “administratively complete” and will not need further review. Due to the standardized submission structure, the FDA also foresees that fewer questions will need to be answered by submitting parties.
Companies may request to participate in the limited pilot program and are eligible if their submission would be reviewed by the Office of Device Evaluation’s Division of Cardiovascular Devices, Division of Neurological and Physical Medicine Devices, Division of Orthopedic Devices, or Division of Surgical Devices. This group represents an increase in the number of companies that are eligible, according to an article recently published by the Regulatory Affairs Professional Society (RAPS). Originally only a few companies in the Division of Cardiovascular Devices were allowed to participate.
Applications to participate in the program will be accepted through December 31, 2014, or as program needs allow, according to the eSubmission website. A sample of 100 submissions will be processed during this pilot study of the system.