The following new items were added to the CDRH web pages on April 26, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.
- Multiple Function Device Products: Policy and Considerations - Draft Guidance for Industry and Food and Drug Administration
- Digital Health Software Precertification (Pre-Cert) Program
- User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018
- Federal Register: Multiple Function Device Products: Policy and Considerations
- Transcripts posted for March 29 - 30, 2018 Clinical Chemistry and Clinical Toxicology Devices Panel meeting
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