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lecture24 - 1 3.051J/20.340J Lecture 24 FDA Approval...

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1 3.051 J / 20 .340 J 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
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2 3.051 J / 2O .340 J 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- pressure cuffs, powered wheelchairs Class III: require pre-market approval devices that: “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury” Further regulation by the FDA under: 1990 Safe Medical Devices Act 1992 Medical Device Amendments 1997 FDA Modernization Act (Section 204)
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3 3.051 J / 20 .340 J FDA Regulatory Branches Center for Device and Radiological Health (CDRH): medical devices Center for Drug Evaluation and Research (CDER): drugs Center for Biologic Evaluation and Research (CBER): biological therapeutics combination products (therapeutic + device) may fall under any of above Premarket Approval Process for Class III Devices Established in: Title 21 Code of Federal Regulations (CFR) Part 814 1. Administrative and limited scientific review - conducted by FDA personnel within 45 days of receipt - determines if application is of sufficient quality for filing - “filing” initiates 180-day review clock
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This note was uploaded on 11/11/2011 for the course BIO 2.797j taught by Professor Matthewlang during the Fall '06 term at MIT.

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lecture24 - 1 3.051J/20.340J Lecture 24 FDA Approval...

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