What Happens When FDA Ends Medical Device and IVD Emergency Use Authorizations (EUAs)?

Throughout the spring and summer of 2020, there was a mad rush to get ventilators, COVID-19 tests, masks, and personal protective gear on the market as quickly as possible. The existing supply of FDA-cleared / -approved devices and in vitro diagnostics (IVDs) could not come close to filling the need, so FDA granted emergency use authorizations (EUAs) for dozens of products. Established medical device manufacturers jumped in to fill the void but so did companies that had no previous experience […]

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Preparing for a Notified Body Medical Device Clinical Audit

Public speaking. Root canals. Buying a used car. Being audited. Which do you dread most? Yes, there are unicorns out there who actually enjoy audits, but most medical device regulatory professionals endure them as part of the job. While preparing for an audit is less than fun, going through an audit for which you were unprepared elevates “unfun” to a whole new level. You can only hide under your desk (or remain off camera) for so long. Of course, you […]

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New EU IVDR Compliance Deadlines – Everything You Wanted to Know…and Then Some

The European Commission – after catching heat from Notified Bodies and industry players alike – finally came to the conclusion that perhaps forcing a May 2022 compliance deadline on thousands of ill-prepared in vitro diagnostic (IVD) manufacturers was not going to end well. As such, the recent decision by the commission to create a rolling action related to the IVDR date of application for many classes of devices was an 11th-hour mea culpa that was painfully obvious to IVD manufacturers […]

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Evaluating and Accepting Medical Device and IVD Residual Risk

Medical device manufacturers and regulators generally have different goals, but one thing they have in common is a desire to make sure devices are safe and effective. To achieve that, regulatory managers often spend a substantial amount of time analyzing, evaluating, and controlling all manner of risks. Of course, risk can never be entirely eliminated, and despite your best efforts at controlling them, there will always be what is called “residual risk.” The question for many is how residual risk […]

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