- General Considerations for Animal Studies for Cardiovascular Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Guideline for Industry and Food and Drug Administration
- Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection - Draft Guideline for Industry and Food and Drug Administration Staff
- eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
- Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff
- Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Guidance for Industry and Food and Drug Administration Staff
- Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff
You may also want to take a look at my previous post: