- Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
- Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff
- Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff
- Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff
- Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
- Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff
- Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff
- Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff
- Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: John Cunningham Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff
- Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance for Industry and Food and Drug Administration Staff
- Reporting of Computational Modeling Studies in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Custom Device Exemption; Draft Guidance for Industry and Food and Drug Administration Staff
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff
Please see my previous blogs:
New FDA Medical Device Guidance Documents for the 1st Quarter 2013
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015
