New FDA Medical Device Guidance Documents for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New FDA Medical Device Guidance Documents are now available:

• General Considerations for Animal Studies for Cardiovascular Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Manufacturing Site Change Supplements: Content and Submission - Draft Guidance for Industry and Food and Drug Administration Staff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• Unique Device Identification: Convenience Kits - Draft Guidance for Industry and Food and Drug Administration Staff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:

New FDA Medical Device Guidance Documents for the 3rd Quarter 2015