Regulations.gov document
Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices
Proposed Rule · FDA-2013-N-0080 · posted Feb 25, 2013
Key facts
| Document ID | FDA-2013-N-0080-0001 |
|---|---|
| Title | Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices |
| Document type | Proposed Rule |
| Subtype | Notice of Proposed Rulemaking (NPRM) |
| Agency | FDA |
| Docket | FDA-2013-N-0080 |
| Posted | Feb 25, 2013 |
| Federal Register citation | 78 FR 12664 |
| FR document number | 2013-04201 |
| CFR | 21 CFR Parts 807, 812, and 814 |
| Comment period opens | Feb 25, 2013 |
| Comments due | May 29, 2013 |
| Effective date | Feb 25, 2013 |
At a glance
- 10–99 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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