MedicalDeviceLaw医疗器械法规课件.ppt

1、Medical Device Lawn 2020/11/41FDAnFDA 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 Years2020/11/42Safety,Not EfficacynNo Regulation of EfficacynSafety Only As Re

2、gards Direct HazardnNo Consideration of Danger of Improper Treatment2020/11/43Congressional HearingsnEarly 1970snPost-WW II Expansion of TechnologynNecessary For ICU and Specialty SurgerynAn Integral Part of Modern Medicine2020/11/44High Risk DevicesnPacemakersnSubject to Catastrophic FailurenAlso B

3、ribery IssuesnAnesthesia MachinesnMarginally Competent PersonnelnThe O-RingnCongress Decides to Regulate DevicesnMDA of 19762020/11/45Medical Device Amendments of 1976nShifted from Post-Market to Pre-MarketnPMAnLike DrugsnEstablished Risk ClassesnClass I-Low RisknClass II-Moderate RisknClass III-Hig

4、h Risk2020/11/46Existing 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 Support2020/11/47360k(a)nExcept as provided in subsection(b)of this section,no State or politi

5、cal 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

6、to any other matter included in a requirement applicable to the device under this chapter.2020/11/48Exempt 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

7、)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 if2020/11/49Exemption Requirements Continuedn(1)the requirement is more stringent than a requirement under this chapter wh

8、ich 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.2020/

9、11/410Exemption 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 process2020/11

10、/411Cipollone 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 Preempted2020/11/

11、412Preemption 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?2020/11/413Politics of Preemption under the MDAnWhen did this become an issue?nWho was FDA Commissioner?nWho

12、 was President?nWho were the Presidents Major Supporters?nWhat was the FDAs Position on Preemption?nWhy Did Justice OConnor Say We Should not Care What the FDA Thinks?2020/11/414Medtronic v.LohrnWhat is the device?nWhat Class is it?nHow was it approved?nDoes this mean no review at all?nWhat are Plai

13、ntiffs Claims?2020/11/415Type of Preemption?nWhat are the types of preemption?nWhich type is at issue here?nDid the court find that plaintiffs claims were preempted?nWhy?2020/11/416Justice BreyernWhat was Justice Breyers Approach?nWould he have reached a different result in this case?nWhat did he le

14、ave open?2020/11/417Post MedtronicnWhat questions does Medtronic leave open?nWhat might you counsel a client?nBased on the notes,is the court hostile to preemption?2020/11/418BuckmannWhat is the device?nWas it approved the first time?nWhat did the manufacturer do to get it approved?nWhat was the app

15、roved use?nHow was it really used?nHow did this lead to plaintiffs claims?2020/11/419Private EnforcementnWhat laws do allow private enforcement?nWhy does the government use these?nWhy not use this for the FDA?nWhat was the courts ruling?nHow was the analysis similar to an explicit preemption analysis?2020/11/420