FDA Now Accepts Medical Device Applications Electronically
(Thursday, July 21, 2022)
While electronic submissions for drug and biologics applications have existed for more than a decade, medical device applications still get submitted as printed submissions and electronic copies that must be physically delivered to the FDA headquarters near Washington DC. Finally, this week, FDA started accepting truly electronic submissions for medical device applications and the process is way simpler than that needed for the drug and biologic submissions. Medical device submissions primarily include 510k and PMA applications which need to be prepared per the eCopy guidance or eSTAR interactive PDF. In the past, applicants had to copy the final submission on to a DVD or flash drive and ship that to FDA’s CDRH Document Control Center (DCC). This practice continued even during the pandemic causing an onerous burden on the applicants. With the launch of the CDRH Customer Collaboration Portal (CCP), shipping submissions to the FDA should be thing of the past. The CCP user interface is one of the simplest and easiest to use of any regulatory submissions’ portals known. Any applicant looking to submit a medical device application can request a free account by emailing to CCP@fda.hhs.gov, whereby FDA will provide access to a user-specific account on the CCP. Anyone looking to submit medical device applications to the FDA can request an account. This could be consultants, company representatives, US agents, and even individuals. The request does not pre-specify any conditions for seeking a CCP account. Unlike the Electronic Submissions Gateway (ESG) for all other submissions to the FDA, the CCP does not require any testing or certifications. Once the CCP account is available, any submission can be uploaded to the FDA in three steps: (1) select the format in which the application was prepared, eCopy or eSTAR, (2) upload the zip file containing the entire application, (3) click to confirm that the application meets the FDA requirements, and upload. There is no software needed, no special formatting needed, and no frills. Once submitted, presumably the applications will be processed just as the physical copies were but the process of distribution internally within the FDA must be faster by eliminating the need for FDA’s DCC staff to do that for each received application. The CCP website should be popular and eliminate all traditional submission to the CDRH. Kudos to the CDRH team that created the simplest regulatory submission portal ever.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC