Titles
- Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff1
- Interoperability among office-based physicians in 2015 and 20171
- Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops2
- Investigational enzyme replacement therapy products: nonclinical assessment1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff1
- Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff1
- Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff1
- Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations1
- Medical devices1
- Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff1
- Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff1
- Medicare Part D1
- Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff1
- National Background Check Program for long-term-care providers: assessment of state programs concluded in 2017 and 20181
- Oncology pharmaceuticals: reproductive toxicity testing and labeling recommendations1
- Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations1
- Opioid use disorder: developing depot buprenorphine products for treatment1
- Osteoporosis: nonclinical evaluation of drugs intended for treatment1
- Payment reform1