On January 15, 2020 the FDA Guidance “Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format” came into force, amending formal requirements (paper and electronic copies management) also for 510(k) Premarket submissions.
In accordance with the Executive Orders (Eos) 13771 and 13777, this provision intends to reduce paper and multiple copies in favor of a single dossier’s submission in electronic form. Moreover, the Guidance reduces the number of electronic copies required by the Agency as easily reproducible, thereby improving and streamlining the medical device submission program.
Submissions in electronic form are intended both eCopies, i.e. on CD, DVD or flash drive created and forwarded practices then submitted to FDA, and eSubmissions or documentation relays deriving from an electronic submission template.
The regulations will apply not only to Premarket Notification Submissions (510(k)) pursuant 21 CFR 807.90, but also to Confidentiality of Information Certifications (21 CFR 807.95), Investigational Device Exemption (IDE) applications (21 CFR 812.20), Premarket Approval Applications (PMAs) (21 CFR 814.20), PMA supplements (21 CFR 814.39) and Humanitarian Device Exemption (HDE) Applications (21 CFR 814.104).
The rules will apply both to devices managed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and it will be immediately effective.