Medical-Device-Law医疗器械法规.pptVIP

Medical Device Law FDA FDA Regulated Devices From the Beginning Hubbard Electrometer Cases Magnetic Healing Cases Original Law Required Proof of Harm Post-Market, not Pre-Market Could Tie the FDA Up in Court for Years Safety, Not Efficacy No Regulation of Efficacy Safety Only As Regards Direct Hazard No Consideration of Danger of Improper Treatment Congressional Hearings Early 1970s Post-WW II Expansion of Technology Necessary For ICU and Specialty Surgery An Integral Part of Modern Medicine High Risk Devices Pacemakers Subject to Catastrophic Failure Also Bribery Issues Anesthesia Machines Marginally Competent Personnel The O-Ring Congress Decides to Regulate Devices MDA of 1976 Medical Device Amendments of 1976 Shifted from Post-Market to Pre-Market PMA Like Drugs Established Risk Classes Class I - Low Risk Class II - Moderate Risk Class III - High Risk Existing Devices Grand-fathered in pre-existing Devices 510(k) “Substantially equivalent” to a pre-1976 Device Only gets GMP Review FDA Was To Evaluate Existing Devices No Money No Political Support 360k(a) Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. Exempt requirements Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if— Exemption Requirements Continued (1) the requirement is more st