Regulations.gov document
Submission and Review of Sterility Information in Premarket Notification (510(k))…
Notice · FDA-2008-D-0611 · posted Jan 21, 2016
Key facts
| Document ID | FDA-2008-D-0611-0016 |
|---|---|
| Title | Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2008-D-0611 |
| Posted | Jan 21, 2016 |
| Federal Register citation | 81 FR 3436 |
| FR document number | 2016-01093 |
| Comment period opens | Jan 21, 2016 |
| Comments due | Mar 22, 2016 |
| Effective date | Jan 21, 2016 |
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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