Educational resources and training opportunities for healthcare professionals, industry, consumers, and academia. Topic Paragraphs FDA Learning Portal for Students, Academia, and Industry Find education and resources related to FDA’s regulatory, product quality, and safety responsibilities. Learn More Navigate the Training and Continuing Education Section Clinical Investigator Training Course Annual training for medical professionals conducting clinical …
Office of Criminal Investigations The Office of Criminal Investigations (OCI) conducts and coordinates criminal investigations. Report suspected criminal activity here. Learn More Compliance Manuals Official documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel Compliance Actions and Activities Compliance activities including enforcement actions and reference materials such as policies and …
Inspections, Compliance, Enforcement, and Criminal Investigations Read More »
Products, Guidance & Regulations FDA’s approach to regulating tobacco products is grounded in science and uses the full power of the law to protect public health. Compliance, Enforcement & Training FDA vigorously enforces the Tobacco Control Act (TCA), which provides FDA with a wide array of powerful regulatory tools to protect the health of all …
What We Do Information about FDA’s mission, what FDA does and does not regulate, and the laws FDA enforces. Learn More Jobs and Training at FDA Vacancies, fellowships, internships, and graduate and faculty programs; employment benefits; and ethics FDA Organization FDA organization charts, contact information, and descriptions FDA History Stories, information and resources about FDA’s …
Topic Paragraphs About Combination Products Combination product definition, reports, examples and common questions. Learn More Navigate the Combination Products Section Guidance & Regulatory Information Combination products rules, regulations, and guidance documents. Classification and Jurisdictional Information Jurisdictional information for human medical products. Feedback on Combination Products Details on how to leave feedback with the Office of …
Navigate the Regulatory Information Section Rules & Regulations Summary of the FDA’s process for rulemaking. Laws Enforced by FDA The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section. Standards FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities. Food and Drug Administration …
Learn about FDA’s programs to monitor product safety, including recalls, safety alerts, problem reporting, and postmarket monitoring systems. Topic Paragraphs Recalls, Market Withdrawals, & Safety Alerts FDA and industry press releases regarding product recalls. Learn More Navigate the Safety Section Report a Problem Useful tools for consumers and health professionals to report problems (adverse reactions) …
Innovation and Improvements to Medical Device Sterilization Techniques The FDA announced selection results of the two Innovation Challenges and the new Ethylene Oxide Sterilization Master File Pilot Program. Learn More Device Advice Information, education, and support for industry Medical Device Safety Safety Communications, Recalls, Letters to Health Care Providers, Reporting Adverse Events (MDR and MedSun) …
Radiation-Emitting Products and Procedures A-Z index of products used in medical imaging, surgery, security systems, home and business, entertainment, and tanning Radiation Safety Safety programs, including medical imaging and electromagnetic interference (EMC), plus safety alerts and reporting a problem Mammography Quality Standards Act and Program MQSA regulations, guidance, inspections, reports, and consumer information Electronic Product …
Allergenics Allergen Extracts, Allergen Patch Tests, Antigen Skin Test Blood & Blood Products Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests Cellular & Gene Therapy Products Gene-based Treatments, Cell-based Treatments, Cloning Guidance, Compliance & Regulatory Information Guidance, Rules, SOPPS, Establishment Registration, Enforcement, Compliance Tissue & Tissue Products Bone, Skin, Corneas, Ligaments, Tendons, Stem …