FDA has the authority to require Sponsors to conduct a Post-Approval Study (PAS) at the time of approval of 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?
Topics: Post Approval Studies, FDA, Pre-Market Approval, IDE Studies
A group of us found ourselves asking this very question after a monitoring visit…what is the difference between a compassionate use subject and a subject who is enrolled in a study without meeting all the inclusion/exclusion criteria (planned protocol deviation)? In both cases the subject does not meet inclusion/exclusion criteria.
As always, we took it to the Federal Regulations/Guidances to see what they said.
Topics: Compassionate Use, Protocol Deviations, FDA
During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A
From the FDA’s perspective, did the Sponsor do enough?
Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Clinical Monitoring
We have all had sites that close prior to the study actually being completed. It is always asked if the site’s IRB allows them to close the study and submit the Sponsor’s final report when the study is completed or if the study needs to remain open at the site to allow the final report to be received by the IRB.
If the study needs to remain open with the IRB, this can become time consuming and costly if the study completion is several years away. The site would need to submit for Continuing Review each year until the Sponsor’s final report is received.
Topics: FDA, IRB, Sponsor Report, Study Closure
Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.
Topics: Principal Investigator, Clinical Investigational Plan, FDA, 1572 Form, ICH GCP E6 8.2.2
On April 17, 2014 the FDA published a draft guidance on Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.
Topics: FDA, Investigational Device Exemption, Case Presentations, IDE
When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.
Topics: FDA, Medical Devices, Compassionate Use
For over 20 years, manufacturers have submitted post-market medical device reports (MDRs) to the FDA in a hard copy via the mail. In 2008, the FDA starting allowing reports to be submitted electronically on a voluntary basis. In August 2009, the FDA drafted a guidance for electronic submissions of MDRs. Comments were accepted on this guidance until November 2009. On February 14, 2014, the Final Rule for this guidance was published which goes into effect August 14, 2015.
Topics: FDA, Medical Device Reporting, MDRs, 21 CFR 803
When is emergency use of unapproved devices acceptable? The Federal Regulations explicitly state how an unapproved device should be used in an emergency situation by a physician. The FDA website also provides a training presentation on this topic.
Topics: FDA, 21 CFR 812, Unapproved Devices
Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.
Topics: FDA, Principal Investigator, Clinical Investigational Plan
A quick search of the internet reveals that sites often wonder who is able to serve as the Principal Investigator of a study. Does the PI have to have a medical license or can non-physicians (PhDs, DOs, PsyDs, DPT) also serve as the PI?
Topics: FDA, Good Clinical Practice, Investigator Qualifications
