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Lecture 7_Datlof

Lecture 7_Datlof - Clinical Trials of Medical Devices...

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Clinical Trials of Medical Devices Steven B. Datlof, M.D., J.D. Hogan Lovells US LLP Product Development 101 May 11, 2011
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www.hoganlovells.com 2 Outline FDA Oversight of Clinical Trials Medical Device Clinical Trial Design: Pivotal Trial Example: Charité Artificial Disc Conducting Clinical Trials Informed Consent, Data Oversight, Financial Disclosure
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FDA Oversight of Clinical Studies
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The Investigational Device Exemption Application
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www.hoganlovells.com 5 Investigational Device Exemptions (IDE) - Purpose To encourage, to the extent consistent with public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose. 21 CFR § 812.1 (a)
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www.hoganlovells.com 6 IDE Applicability All Clinical Investigations of Devices to Determine Safety and Effectiveness Degree of Applicability Full Requirements: Significant Risk Device Studies Abbreviated Requirements: Non-Significant Risk Device Studies
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www.hoganlovells.com 7 When Is IDE Approval Required? For 510(k) or PMA if study presents “significant risk” Significant risk device means an investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
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www.hoganlovells.com 8 Significant Risk vs. Non-Significant Risk Studies Significant Risk Non-Significant Risk FDA Approval Yes No IRB Approval Yes Yes Informed Consent Yes Yes Reporting Yes Limited Record keeping Yes Limited Used for 510(k) or PMA Yes Yes
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www.hoganlovells.com 9 Clinical Data Requirements 510(k) Majority of 510(k) notices are cleared with only bench and/or animal data Approximately 10% of premarket notifications require clinical data Clinical study designs are usually more flexible than PMA clinical study designs De novo pathway Normally require clinical data Again, clinical study designs are usually more flexible than PMA clinical study designs PMA Require clinical data to provide valid scientific evidence of device’s safety and effectiveness Typically requires a hypothesis-driven, randomized, controlled clinical trial with validated primary endpoints
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www.hoganlovells.com 10 Sponsor Responsibilities General responsibilities (21 CFR § 812.40) FDA and IRB approval (812.42) Select investigators and monitors (812.43) Information to investigators (812.45) Monitoring (812.46) Recordkeeping (812.140(b)) Reporting (812.150(b))
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www.hoganlovells.com
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  • Spring '11
  • KOP
  • Clinical trial, investigator, Charité Artificial Disc, Pivotal Trial Example, Oversight of Clinical Trials · Medical Device Clinical Trial Design

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