Submissions and Approvals

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The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock. View

Regenerative Medicine outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify. The FDA granted RMAT designation to 12 organizations in 2017 — the first year of the program. Now is the time to get in the mix, work with the FDA to develop the program and improve your chance of being one of the next RMAT designees. View

The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View

Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View

The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies. But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way? View

Deep within the still-new 21st Century Cures Act lies a clause that could alter FDA medical device regulation in ways no one can yet know ... and have implications far beyond companies now subject to FDA regulation. View

“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

Marketing into Asia just got more complicated for device and IVD makers. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected. Plus, lest you forget, most IVDs require clinical trials in China. View

Order your copy of the 510(k) Change Analysis brief for step-by-step instruction on deciding whether you need to submit a new 510(k) if you change an existing device. View

There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View