Medical-Device-Law医疗器械法规.ppt

Medical-Device-LawMedical-Device-Law医医疗器械法规疗器械法规FDAnFDA Regulated Devices From the BeginningnHubbard Electrometer CasesnMagnetic Healing CasesnOriginal Law Required Proof of HarmnPost-Market, not Pre-MarketnCould Tie the FDA Up in Court for YearsSafety, Not EfficacynNo Regulation of EfficacynSafety Only As Regards Direct HazardnNo Consideration of Danger of Improper TreatmentCongressional HearingsnEarly 1970snPost-WW II Expansion of TechnologynNecessary For ICU and Specialty SurgerynAn Integral Part of Modern MedicineHigh Risk DevicesnPacemakersnSubject to Catastrophic FailurenAlso Bribery IssuesnAnesthesia MachinesnMarginally Competent PersonnelnThe O-RingnCongress Decides to Regulate DevicesnMDA of 1976Medical Device Amendments of 1976nShifted from Post-Market to Pre-MarketnPMAnLike DrugsnEstablished Risk ClassesnClass I - Low RisknClass II - Moderate RisknClass III - High RiskExisting DevicesnGrand-fathered in pre-existing Devicesn510(k)n“Substantially equivalent” to a pre-1976 DevicenOnly gets GMP ReviewnFDA Was To Evaluate Existing DevicesnNo MoneynNo Political Support360k(a)nExcept 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 requirementsnUpon 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 Continuedn(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.Exemption CasesnState Consumer FraudnState Regulation of ProfessionsnHearing AidsnMA set standards for disclosure and marketing of hearing aidsnThese were challenged as additional requirements under 360knCourt Struck themnMA would need to ask for an exemption under the statutory processCipollone v. Liggett GroupnTobacco Labeling Act (1967?)nRequired Standard LabelsnSaid State Could Impose No Other Labeling RequirementsnLawyers Knew This Was Preemption LanguagenCourt Found State Tort Claims Related to Warnings are Requirements that Would Effect Labeling, Thus Are PreemptedPreemption v. Regulatory CompliancenAre they the same?nWhat are the procedural issues?nWhy does state v. federal court matter?nWhich would you prefer to have if you are a defense lawyer?nWhy?Politics of Preemption under the MDAnWhen did this become an issue?nWho was FDA Commissioner?nWho was President?nWho were the President’s Major Supporters?nWhat was the FDA’s Position on Preemption?nWhy Did Justice O’Connor Say We Should not Care What the FDA Thinks?Medtronic v. LohrnWhat is the device?nWhat Class is it?nHow was it approved?nDoes this mean no review at all?nWhat are Plaintiff’s Claims?Type of Preemption?nWhat are the types of preemption?nWhich type is at issue here?nDid the court find that plaintiff’s claims were preempted?nWhy?Justice BreyernWhat was Justice Breyer’s Approach?nWould he have reached a different result in this case?nWhat did he leave open?Post MedtronicnWhat questions does Medtronic leave open?nWhat might you counsel a client?nBased on the notes, is the court hostile to preemption?BuckmannWhat is the device?nWas it approved the first time?nWhat did the manufacturer do to get it approved?nWhat was the approved use?nHow was it really used?nHow did this lead to plaintiff’s claims?Private EnforcementnWhat laws do allow private enforcement?nWhy does the government use these?nWhy not use this for the FDA?nWhat was the court’s ruling?nHow was the analysis similar to an explicit preemption analysis?结束结束。