MedicalDeviceLaw医疗器械法规课件

1、Medical Device Law 2020/11/41Medical Device Law 2020/11/41FDAFDA Regulated Devices From the BeginningHubbard Electrometer CasesMagnetic Healing CasesOriginal Law Required Proof of HarmPost-Market, not Pre-MarketCould Tie the FDA Up in Court for Years2020/11/42FDAFDA Regulated Devices From Safety, No

2、t EfficacyNo Regulation of EfficacySafety Only As Regards Direct HazardNo Consideration of Danger of Improper Treatment2020/11/43Safety, Not EfficacyNo RegulatCongressional HearingsEarly 1970sPost-WW II Expansion of TechnologyNecessary For ICU and Specialty SurgeryAn Integral Part of Modern Medicine

3、2020/11/44Congressional HearingsEarly 19High Risk DevicesPacemakersSubject to Catastrophic FailureAlso Bribery IssuesAnesthesia MachinesMarginally Competent PersonnelThe O-RingCongress Decides to Regulate DevicesMDA of 19762020/11/45High Risk DevicesPacemakers202Medical Device Amendments of 1976Shif

4、ted from Post-Market to Pre-MarketPMALike DrugsEstablished Risk ClassesClass I - Low RiskClass II - Moderate RiskClass III - High Risk2020/11/46Medical Device Amendments of 1Existing DevicesGrand-fathered in pre-existing Devices510(k)“Substantially equivalent” to a pre-1976 DeviceOnly gets GMP Revie

5、wFDA Was To Evaluate Existing DevicesNo MoneyNo Political Support2020/11/47Existing DevicesGrand-fathered360k(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 r

6、equirement-(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.2020/11/48360k(a)Exce

7、pt as provided in sExempt requirementsUpon 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 regulati

8、on, a requirement of such State or political subdivision applicable to a device intended for human use if2020/11/49Exempt requirementsUpon applicExemption Requirements Continued(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an e

9、xemption 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.2020/11/410Exemption Requirements ContinuExem

10、ption CasesState Consumer FraudState Regulation of ProfessionsHearing AidsMA set standards for disclosure and marketing of hearing aidsThese were challenged as additional requirements under 360kCourt Struck themMA would need to ask for an exemption under the statutory process2020/11/411Exemption Cas

11、esState Consumer Cipollone v. Liggett GroupTobacco Labeling Act (1967?)Required Standard LabelsSaid State Could Impose No Other Labeling RequirementsLawyers Knew This Was Preemption LanguageCourt Found State Tort Claims Related to Warnings are Requirements that Would Effect Labeling, Thus Are Preemp

12、ted2020/11/412Cipollone v. Liggett GroupTobaPreemption v. Regulatory ComplianceAre they the same?What are the procedural issues?Why does state v. federal court matter?Which would you prefer to have if you are a defense lawyer?Why?2020/11/413Preemption v. Regulatory ComplPolitics of Preemption under

13、the MDAWhen did this become an issue?Who was FDA Commissioner?Who was President?Who were the Presidents Major Supporters?What was the FDAs Position on Preemption?Why Did Justice OConnor Say We Should not Care What the FDA Thinks?2020/11/414Politics of Preemption under tMedtronic v. LohrWhat is the d

14、evice?What Class is it?How was it approved?Does this mean no review at all?What are Plaintiffs Claims?2020/11/415Medtronic v. LohrWhat is the dType of Preemption?What are the types of preemption?Which type is at issue here?Did the court find that plaintiffs claims were preempted?Why?2020/11/416Type

15、of Preemption?What are thJustice BreyerWhat was Justice Breyers Approach?Would he have reached a different result in this case?What did he leave open?2020/11/417Justice BreyerWhat was JusticePost MedtronicWhat questions does Medtronic leave open?What might you counsel a client?Based on the notes, is

16、 the court hostile to preemption?2020/11/418Post MedtronicWhat questions dBuckmanWhat is the device?Was it approved the first time?What did the manufacturer do to get it approved?What was the approved use?How was it really used?How did this lead to plaintiffs claims?2020/11/419BuckmanWhat is the device?2020