With the trials IMARC Research has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. However, on one of the projects we were working on FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted.
On this particular
- Audited 4 Japanese sites and Sponsor
- Audited European Sponsor for registry sites/oversight
- Adverse Event and Device Audits for Sponsors
- Audit Prep for 5 sites receiving audit
- Followed up on all mock audit findings
The site inspected was among the top enrollers in this particular study, and was an academic medical center. We've recorded some of the challenges from this case study in a whitepaper to help others prepare for the ever winding pathway to approval. Along this particular
Waiting for decisions from FDA or other regulatory bodies can be worrisome. Eliminate the worry by being prepared. Going through a “mock” audit before an FDA audit takes place can help ensure you have the highest probability of earning favorable outcomes.
Check out our case study and let us know what types of inspections you have undergone. What were the outcomes? Share your experiences below.
Photo Credit: Eddi 07- Free Stock