Recently Posted Guidance Documents on Drugs, Tobacco, Digital Health, Blood, Clinical Trials, and Devices

Drugs

12/6/2017 Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry

Tobacco

12/7/2017  Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

Emerging Technology, Laws and Regulations, Digital Health

12/8/2017 Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff

12/8/2017  Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff

12/8/2017 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff

Premarket, PMA, Biotechnology, IDE, Emerging Technology, HUD/HDE, Orthopedic Devices 

12/5/2017  Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Clinical Trials/GCP, IDE

12/5/2017 FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff

Blood

12/5/2017  Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry