MedicalDeviceLaw医疗器械法规

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
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
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 Law
FDA
FDA Regulated Devices From the Beginning
Hubbard Electrwk.baidu.commeter Cases Magnetic Healing Cases
Original Law Required Proof of Harm Post-Market, not Pre-Market Could Tie the FDA Up in Court for Years
Exemption Requirements
Continued
(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or (2) the requirement-(A) is required by compelling local conditions, and (B) compliance with the requirement would not cause the device to be in violation of any applicable requirement 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 Cases
State Consumer Fraud State Regulation of Professions Hearing Aids
MA set standards for disclosure and marketing of hearing aids
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.
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