Case Study: Medical Device FDA Inspection

With the trials IMARC Research has monitored, our experience has been that the FDA has begun Case Study Medical Device FDA Inspection 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 project IMARC Research provided both contract monitoring and auditing services for a large medical device manufacturer on a randomized, peripheral stent study that involved over 40-sites on three continents. Other elements included:

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

Interested in how the FDA inspection turned out? Check out the whitepaper “Pre-PMA FDA Inspection.”

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 pathway we faced many challenges, and documented the solutions in this case study.

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.

How prepared are you for approval?

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