How to prepare your medical device company for an US FDA inspection
FDA visits can be challenging, especially when your company isn’t quite up-to-speed in complying with the required regulatory records and reports. Here are some key areas where companies often trip up!
On occasion, regulatory inspectors will announce their visit ahead of time but too often companies take this announcement far too lightly. This is a mistake especially since the regulations are becoming more stringent and the Regulator, themselves, are more vigilant. These pre-announced visits often come about for Class II and Class III medical devices.
The FDA may also pre-announce a visit because of competitor activity, introduction of a new competitor product, or any common grounds of a regulatory check. Historically, FDA announces their visit schedule. This schedule is not focusing on the reason for the visit but just a basic timeline for you to prepare and keep the documents updated.
The company needs to keep an eye on what’s happening in the marketplace and the industry to monitor what is happening with their competitors and other industry players. The most common reason for an FDA visit is because of medical device reports logged on the FDA’s MAUDE database which records “suspected device-associated deaths, serious injuries and malfunctions”. It is critical that companies continually monitor feedback and reports on their own devices and take appropriate action.
How should you prepare for a FDA inspection?
Here are some tips:
- DO review the FDA guidelines (FDA QSIT guide). The guidelines tell you how the FDA runs inspections so that you can have your team and documentation prepared.
- Have your schedule of activities ready for the day. From the arrival of the FDA officials to their departure, everything should be in place, and the primary contacts of departments should be clearly documented and available on the day of the visit.
- DON’T give the FDA inspector access to a system or filing room to look through themselves. You must have everything ready to give to them. For example, you already know the FDA is interested in your CAPA procedures, so have a log or list ready — the same goes for your complaints.
- Internal audits - Have a robust internal auditing program. This should be active and ideally tougher than any FDA inspection or external audit. Have a sharp focus on the internal auditing system. Make it a regular practice and not just a pre-visit procedure.
- Documentation - Have a structured documentation process. Keep the documents updated and ready. Focus on having a regular practice for reporting, where all events of the company are documented. Apart from the visit, these documents can serve as a quick reference point in the future.
- Design controls – all process records in risk management, quality control and production procedures should be in place. The Regulator might look at the copy of your 510(k). Have a clear focus on having a solid design control procedure and documentation in place.
- To avoid any stumbling blocks during the visit, ensure all your processes are up-to-date and that personnel are following due process.
By following these tips, you’ll have a smoother and less stressful time during the US FDA visit. Remember to keep reporting your latest medical device reports to the Regulators.
If you’re in need of 510(k) guidance or any other Medical Device Regulatory assistance, feel free to contact our experts at Med-Di-Dia
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