The following new items were added to the CDRH web pages on January 30, 2018. Previous CDRH New items can be found on the CDRH New webpage.
- Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs)
- Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
- Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error
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