Regulations.gov document

Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies…

Rule · FDA-2018-N-0628 · posted Dec 16, 2019

Key facts

Document ID FDA-2018-N-0628-0020
Title Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format
Document type Rule
Subtype Final Rule
Agency FDA
Docket FDA-2018-N-0628
Posted Dec 16, 2019
Federal Register citation 84 FR 68334
FR document number 2019-27047
CFR 21 CFR Parts 807, 812, and 814
Comment period opens Dec 16, 2019
Effective date Dec 16, 2019

At a glance

  • 1–9 Pages
  • 10–99 Public comments on this docket

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