The following new items were added to the CDRH web pages on October 25, 2017. Previous CDRH New items can be found on the CDRH New webpage.
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160056 added)
- CDRH Industry Basics Workshop – Nonconforming Product and Complaint Files - November 7th, 2017
- Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff
- Breakthrough Devices Program - Draft Guidance for Industry and Food and Drug Administration Staff
- Class I Medical Device Recall: OriGen Biomedical Medical Recalls Reinforced Dual Lumen ECMO Catheter Due to Separation
- Mammography Facility Adverse Event and Action Report - October 24, 2017: Clinics of North Texas L.L.P.
- Mammography Facility Adverse Event and Action Report - October 24, 2017: Tarrant County Hospital District dba John Peter Smith Hospital
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