Device & Drug Safety 7
- Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- Labeling Requirements for Surgical Staplers and Staples for Internal Use
- Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)
- Safety Considerations for Flow Restrictors in Oral Liquid Drug Products to Prevent Accidental Ingestion by Children (DRAFT)
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices