CDRH New Update

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