Regulations.gov document
Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies…
Proposed Rule · FDA-2018-N-0628 · posted Sep 13, 2018
Key facts
| Document ID | FDA-2018-N-0628-0001 |
|---|---|
| Title | Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format |
| Document type | Proposed Rule |
| Subtype | Notice of Proposed Rulemaking (NPRM) |
| Agency | FDA |
| Docket | FDA-2018-N-0628 |
| Posted | Sep 13, 2018 |
| Federal Register citation | 83 FR 46444 |
| FR document number | 2018-19865 |
| CFR | 21 CFR Parts 807, 812, and 814 |
| Comment period opens | Sep 13, 2018 |
| Comments due | Dec 13, 2018 |
| Effective date | Sep 13, 2018 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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