Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format
fda-device · Food and Drug Administration · Rule · Published 2019-12-16 · Effective 2020-01-15 · 84 FR 68334
Document
Document number
2019-27047
Federal Register citation
84 FR 68334
CFR reference
21 CFR 807
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2019-12-16
Effective date
2020-01-15
HHS docket
Docket No. FDA-2018-N-0628
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices.