- Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
- Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff
- Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and Food and Drug Administration Staff
- Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and Food and Drug Administration Staff
- Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff
- Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Global Unique Device Identification Database (GUDID) - Guidance for Industry
For more information, see my previous blogs:
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015
