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What Does the FDA Regulate?
Foods safety of all food products, labeling, bottled water, food additives, infant formulas Dietary Supplements Human Drugs product approvals, OTC and prescription drug labeling, drug manufacturing standards Vaccines, Blood Products, and Other Biologics product and manufacturing establishment licensing, safety of the nation's blood supply research to establish product standards and develop improved testing methods Medical Devices from simple items like tongue depressors, to complex technologies such as heart pacemakers premarket approval of new devices, manufacturing and performance standards tracking reports of device malfunctioning and serious adverse reactions Electronic Products products that give off radiation, such as microwave ovens and X-ray equipment radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities Cosmetics Safety, labeling Veterinary Products livestock feeds, pet foods, veterinary drugs and devices Tobacco Products
25% of the US economy
Forbes, 2012
FDA
– Margaret Hamburg, MD FDA Commissioner
– FDA Justification of Estimates for Appropriations Committees, 670 pg – Budget for 2000 was $1.3B
- 8 Divisions
- Center for Devices and Radiological Health
– Jeffery Shuren, MD – 1,413 Employees
Get safe and effective medical devices to market as quickly as possible… … while ensuring that medical devices currently
remain safe and effective. Help the public get science-based accurate information about medical devices and radiological products needed to improve health.
CDRH Mission
Get safe and effective medical devices to market as quickly as possible… … while ensuring that medical devices currently
remain safe and effective. Help the public get science-based accurate information about medical devices and radiological products needed to improve health.
Bill Sutton: Overview of Regulatory Requirements for Medical Devices
Current Regulation of Vascular Devices
What Is Right With the System?
- Significant resources have been devoted
- Recent efforts to clarify pathways
- Innovation approval pathway
- New teaching materials
- Entrepreneur in residence program
- Safety is being achieved
– 99.6% of 510(k) and PMA devices did not experience a recall in last 5 years
– Hall R. Using recall data to assess the effectiveness of the FDA clearance process. Institute of Medicine, Washington DC, July, 2010.
