Guide to FDA's 510(k) Clearance Process, 2nd Edition
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The FDA has made significant revisions to its 510(k) clearance process. Are you up-to-date on the major changes?
The newly revised Guide to FDA’s 510(k) Clearance Process, 2nd Edition, provides small and mid-sized medical device manufacturers with the background, the current conditions, and the recent changes to FDA’s 510(k) clearance process.It will keep you updated and informed of the revised clearance requirements. The Guide is a complete one-stop resource, with tips and advice to getting your device through the clearance process.
- The Guide to FDA’s 510(k) Clearance Process, 2nd Edition:
- Gives you step-by-step assistance in getting your new device through the premarket clearing process.
- Outlines the FDA decision-making criteria — intended use, risk assessment and more.
- Brings a comprehensive understanding of what the FDA is looking for now — and where they are heading in the near future.
- Covers the entire classification process; who has to file; how to file and what classifies as "Special" and significant modification.
- Is a clear and concise tool that breaks through the red tape, and offers the day to day practical information you need to navigate the clearance process.
- Will keep you current on the process changes as they come through from the FDA.
- FDA review times, user fees, the use of outside experts during reviews, the assurance case pilot program, new postmarket requirements for adverse event reporting, third-party reviews, the submission of multiple predicates, the use of standard operating procedures for guidance development and how to report a transfer of ownership.
The updated edition has new information including:
In addition, the book has been reorganized so that the information is presented in order from device concept to market approval, which is the way device manufacturers view and use the process.
The Guide to FDA’s 510(k) Clearance Process, 2nd Edition, is a one-stop resource and compliance guide. This comprehensive book explains the ins and outs of the 510(k) clearance process for medical devices, including the program changes proposed or implemented by the FDA.
We breakdown what every small and mid-size device manufacturer needs to have at their fingertips to successfully navigate the revised 510(k) process.
The Guide gives you a complete understanding of the background behind the scenes so you'll know the why's — allowing you to be better prepared, have the documentation you need, and what to do if you don't.
The Guide allows you to sign up for automatic updates so you'll always remain up to date with the regulation changes, and what they mean to you.
- One-volume reference tool
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