Submissions and Approvals

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Getting Real About Real World Evidence - Webinar Recording/Transcript

$287.00
Real world evidence — “RWE,” so-called — is making its way into your world. Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, walks you through the fast-moving RWE changes currently affecting the agency and business decisions alike. View

New Direct Marking Requirements for UDIs - Webinar Recording/Transcript

$287.00
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

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
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

The CDRH Reorganization - Webinar Recording/Transcript

$287.00
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

Regenerative Medicine - Webinar Recording/Transcript

$287.00
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

Bringing Innovative “Healthy” Consumer Products to Market - Webinar Recording/ Transcript

$287.00
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 to Improve Quality & Compliance - Webinar CD/Transcript

$287.00
“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

How to Get IVD Approval Through CFDA - Webinar Recording/Transcript

$287.00
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

510(k) Change Analysis: Complying with FDA’s Final Guidances

$197.00
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

Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript

$287.00
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

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

$397.00
Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices brings together all the disparate parts of IVD regulations and guidances and provides an expert interpretation of requirements. View

Medical Device Reimbursement Integration - Webinar Recording/Transcript

$287.00
Devicemakers often take a step approach to commercialization: you develop your medical device, get it approved, and then determine a reimbursement policy. That’s not best practice any more. View