Quick Tip: 5 reasons you may invite unwanted FDA scrutiny
Key vulnerabilities in your QMS to review and fix
No one enjoys the idea of having to welcome an FDA investigator at their medical device manufacturing site for an un-announced, for-cause inspection. It creates a lot of anxiety throughout the organization and takes the focus away from daily operations.
FDA utilizes a risk-based approach to enforcement of its regulatory authority over medical device manufacturers. You can get some clues about factors that may prompt the FDA to look at your operations more carefully by reviewing some of their recent actions and reports. Based on a 2018 report on medical device enforcement, some of these factors are listed above.
Keep in mind that the FDA has access to large amounts of data on adverse events, malfunctions and compliance trends. While the data is not perfect, it is sufficient to raise red flags and provide direction to the FDA to prioritize their enforcement activities.
It is important to monitor your own data, and other publicly available industry data to identify these signals as part of a robust post-market surveillance system. Take action before the FDA comes knocking at your door!
