Faegre Baker Daniels and FaegreBD Consulting are pleased to offer news and important information as it becomes available. Please click the button below to subscribe to periodic email updates.
The Institute of Medicine, part of the National Academy of Sciences, issued a report on July 29, 2011, commissioned by the United States Food and Drug Administration (FDA), which recommended an overhaul in the process of medical device regulation. Specifically, the panel concluded that the current 510(k) clearance system is flawed. The Panel advised the FDA to completely redesign the medical device regulation process for medium risk devices, rather than merely tinkering with the 510(k) system.
Various stakeholders, including some in Congress and a coalition of major trade associations and medical device companies, have denounced the Panel's erroneous conclusion that the 510(k) does not evaluate safety and effectiveness and must therefore be replaced. Although FDA itself has stated that it will not eliminate the 510(k) process, the FDA also has stated that it is open to making changes to the process. Overall, the 510(k) process remains under attack and there could well be significant modifications to it.
*Your message has been successfully sent.
In considering prior results, please be aware that: (i) each legal matter is
unique; (ii) prior results are not necessarily representative of all our
matters; and (iii) you should not rely on prior results to predict future
success in similar matters.
Copyright © 2000-2016 Faegre Baker Daniels LLP.
All Rights Reserved. | View Our Disclaimer
Notes: Please do not send confidential information or
sensitive materials through this form.
Transmission of information to us via this feature does not establish an attorney-client relationship. Do not send any information that you would have treated confidentially.