We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Store » Submissions and Approvals » Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation
Other Options
PDF Edition
$397.00
PDF Edition - 3-4 Copies (10% Off)
$357.00
PDF Edition - 5-6 Copies (15% Off)
$337.00
PDF Edition - 7-9 Copies (20% Off)
$317.00
PDF Edition - 10+ Copies (25% Off)
$297.00
Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation
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.
Order Your Copy Today
PDF Edition
Available Format
PDF Edition — $397
Who Will Benefit
Regulatory affairs professionals
Corporate counsel
Lawyers
Lobbyists
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.