The following new items were added to the CDRH web pages on January 12, 2018. Previous CDRH New items can be found on the CDRH New webpage.
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
- Compliance Dates for UDI Requirements
- Feeding Tube Placement Systems - Letter to Health Care Providers
- Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
- Federal Register: Unique Device Identification - Policy Regarding Compliance Dates for Class I and Unclassified Devices
- Federal Register: Medical Devices; Device Tracking
- Federal Register: Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop