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Titles
- Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff1
- Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- Evaluation of devices used with regenerative medicine advanced therapies1
- 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 staff1
- FDA repeatedly adapted emergency use authorization policies to address the need for COVID-19 testing1
- FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments1
- Facet screw systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff1
- Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff1
- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff1
- Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- 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
- Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters1
- Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff1
- Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff1