FDA guidance
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian…
FDA guidance · Final · issued Dec 16, 2019
Key facts
| Title | 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff |
|---|---|
| Status | Final |
| Issue date | Dec 16, 2019 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Biologics Evaluation and Research, Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-1998-D-0281 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents