FREE ON-DEMAND WEBINAR

Post-Market Surveillance for Medical Devices and Combination Products: If a device is FDA cleared or approved, can we assume it’s safe and effective?

When a medical device or combination product is cleared or approved by FDA, can we assume it’s safe and effective?

In a word… NO!

Only 3-5% of adverse events are reported to manufactures or FDA.  Spun in reverse… 95-97% of adverse events are never reported!  If problems are not reported, can we conclude our devices are working perfectly?  Is the absence of evidence, evidence of absence?

Post-market surveillance (PMS) is the process of watching our devices perform while on the market.  PMS is a vital component of the medical device and combination product lifecycle.  Yet historically, the med-tech industry has had a poor record when it comes to PMS.  As a result, PMS requirements have been increasing in the US, the EU and around the globe.  But having an effective PMS system means more than simply meeting the regulatory and quality requirements. 

A strong PMS system cannot simply find problems that may have been missed as part of the pre-market development or quality assurance process.  A strong PMS system can be used to add additional indications, a.k.a. label expansions, which translates to greater revenues for the manufacturer!

Having an effective PMS system is important from both a regulatory and quality perspective.  But can you assume if your PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not!  And when companies make such assumptions, they often find themselves in trouble… not just with the FDA but with product liability attorneys as well! 

In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!