You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)? The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA). The site in question was part of that clinical trial but now the study and enrollment goal has been met and the both the site and study are closed.
Topics: Compassionate Use, IDE Studies
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