麻省理工学院 生物材料课程 lecture 24 FDA Approval Process for Medical Devices.pdf

3.051J/20.340J 1 Lecture 24 FDA Approval Process for Medical Devices The Medical Device Business - $77B U.S. Market (2002) - 13,000 Registered U.S. Manufacturers (2003) many with no commercial products! - 300,000 U.S. Workers (2003) Top 20 devices by revenue (1999): 1) Incontinence supplies 11) Prosthetic knee implants 2) Blood glucose monitoring 12) Lens care products 3) Wound closure products 13) Prosthetic hip implants 4) Implantable defibrillators 14) Patient-montioring equipment 5) Soft contact lenses 15) Mechanical wound closure 6) Orthopedic fixation devices 16) Wound suture products 7) Pacemakers 17) Absorbable polymers 8) Examination gloves 18) Hearing Aids 9) Coronary stents 19) Wheelchairs and scooters 10) Arthroscopic accessories 20) Peritoneal dialysis sets Biomaterials are not regulated—medical devices are Biomaterials are approved for use as part of a specific medical device 3.051J/2O.340J 2 Regulation History 1906 Food and Drug Act - established the FDA - no provisions on medical devices (regulated by the U.S. Postal Service under postal fraud statutes) 1938 Food, Drug and Cosmetic Act - FDA regulation of device misbranding/adulteration (inadequate authority/resources for wide scale regulation) 1976 Medical Device Amendment Classified Devices Regulatory Standards for Safety Efficacy Class I: low risk, general controls sufficient over the counter products-e.g., adhesive bandages, hospital beds Class II: performance standards general control physician controlled distribution-e.g., oxygen masks, blood-