New FDA Medical Device Guidance Documents for the 4th Quarter 2014

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

• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Distinguishing Medical Device Recalls from Medical Device Enhancements - Guidance 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 and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff
• Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff
• Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff
• Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff
• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff
• Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff
• Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff
• Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
• Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)
• Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Transfer of a Premarket Notification (510(k)) Clearance - Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff
• Radiation Biodosimetry Devices - Draft Guidance for Industry and Food and Drug Administration Staff

You'll also want to take a look at my previous postings:

New FDA Medical Device Guidance Documents for the 3rd Quarter 2014

New FDA Medical Device Guidance Documents for the 2nd Quarter 2014

New FDA Medical Device Guidance Documents for the 1st Quarter 2014

And to get the latest information for 2015, check out my new post:

New FDA Medical Device Guidance Documents for the 1st Quarter 2015