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Compliance In Focus
Posted by Jaime Wynbrandt on Fri, Feb 19, 2016

Post-Approval Studies: Similarities and Differences from Pivotal Studies

FDA has the authority to require Sponsors to conduct a Post-Approval Study (PAS) at the time of approval Similarities_and_Differences_from_Pivotal_Studiesof a Pre-Market Approval (PMA) to assess the continued safety and effectiveness of an approved device. Failure to complete a Post-Approval Study could result in the FDA taking away the PMA. How are Post-Approval Studies similar and different to Pivotal Studies?

How are Post-Approval Studies similar to IDE studies?

  • If the study is being conducted to collect data to support either a clinical investigation or marketing application, it must comply with 21 CFR 50 and should comply with 21 CFR 56
    • 21 CFR 50: Protection of Human Subjects
       Must obtain informed consent
    • 21 CFR 56: Institutional Review Boards
      • Must have IRB approval and follow IRB policies 
  • Studies of a cleared device for a new use must comply with the human subject protection (informed consent and additional safeguards for children in research), IRB, and IDE regulations

How are Post-Approval Studies different than IDE studies?

  • Studies of an already cleared medical device or PMA approved device in which the device is used or investigated in accordance with the indications in the cleared labeling are exempt from 21 CFR 812.
  • FDA recommends the Sponsor submit Interim Post-Approval study status reports every 6 months for the first 2 years and annually thereafter.
  • Sponsors follow 21 CFR 814- Premarket approval of medical devices; subpart E– post-approval requirements for PAS studies.
    • There are no requirements for the site in 21 CFR 814
  • Public Disclosure of Post Approval Study information is posted on the FDA website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA_pas.cfm
  • Clinicaltrials.gov statement and the informed consent document
    • FDAAA 801 definition of “applicable clinical trial”, the statement should be in the informed consent document if:
      • Trials of devices: 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post-market surveillance required by FDA
      • Post approval device studies that are interventional in nature
    • Financial Disclosure?
      • Part 54 states that applicants who submit a marketing application for a device have to submit information regarding compensation of any investigator conducting clinical studies covered by the regulation
      • he Sponsor must submit a list of all investigators who conduct covered clinical studies
        • What is a covered clinical study? 21 CFR 54.2 (e)  Covered Clinical Study
        • Based on marketing application or reclassification petition 
        • Applicant may consult with FDA whether “covered clinical study”
        • True PAS would not require Financial Disclosures by this definition

Do you have other examples of how post-approval studies are either similar or different?

The History of Clinical Research

photo credit: 326/365: Behind You 42 via photopin (license)

Topics: Post Approval Studies, FDA, Pre-Market Approval, IDE Studies

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