Devicemaker’s Guide to the 21st Century Cures Act Changing the Face of Medical Device Regulation
The device regulatory landscape is changing.
The newly passed 21st Century Cares Act doesn’t just force an adjustment of the FDA’s policies. It calls for a sea of change in the waters you have learned to navigate so well. Attached to the 2016 “Tsunami Warning Bill” to guarantee passage, the act will bring a tidal wave of new regulations you will have to learn to accommodate.
The act aims to loosen the FDA’s reigns, but in such vague terms that FDA/industry lawsuits are not only likely, they’re almost inevitable. And Congress didn’t set aside money specifically to carry out the act’s provisions, which means it will carve into the FDA’s regular budget — to the tune of $20 million in 2017 — and cause underfunding of some of the agency’s other priorities.
If you want to survive the coming storm — you need to start preparing now.
Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. You will learn:
New exemptions from 510(k) clearance will lift the filing burden from many more Class 1 and Class 2 devices
Software will be virtually de-regulated
Fewer device changes will require FDA review
Vague terms like “in the best interest of patients” and “probable benefit” leave holes you could drive a truckload of lawyers through
Less costly Chinese and Indian testing is likely to be used in vaccine development
The view of Senate opposers who are poised to fight the changes the act mandates
Order your copy of Devicemaker’s Guide to the 21st Century Cures Act and keep up on the wave of changes in medical device regulations.
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Regulatory affairs professionals
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