New FDA Medical Device Guidance Documents for the 2nd Quarter 2016

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

• Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and Food and Drug Administration Staff
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff
• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions, Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff
• Dissemination of Patient-Specific Information from Devices by Device Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff
• Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' - Guidance for Industry and Food and Drug Administration Staff
• Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff
• Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff
• Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff
• Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff