Regulatory
Meeting Regulatory Requirements with FEA
I recently returned from a workshop on Computer Methods for Cardiovascular Devices sponsored by the Federal Drug Administration, the National Heart, Lung, and Blood Institute, and the National Science Foundation
IRS issues medical device tax regs; AdvaMed urges repeal
Today’s release of proposed regulations to implement the $20 million medical device tax scheduled to go into effect next year drew this response from AdvaMed President and CEO Stephen Ubl...
AdvaMed praises de novo legislation
The “Improving Safety, Efficiency & Transparency in Device Regulation Act.” sponsored by Sen. Bob Casey, Jr. (D-PA) and Sen. John McCain (R-AZ), has the full support of AdvaMed, as evidenced by this statement released today by AdvaMed President and CEO Stephen Ubl...
Latest device user-fee agreement could be game-changer, but first . . .
This week’s announced tentative agreement on a new “Medical Device User Fee Act” by FDA, AdvaMed, and other trade associations, including MDMA and MITA, deserves praise and requires scrutiny....
FDA and CMS: A path for parallel approvals for innovative technologies
Parallel FDA and CMS review offers an opportunity to reduce the time it now takes to secure Medicare coverage and payment for innovative new products....
Legislation prompts positive responses from AdvaMed
New legislation introduced to improve the de novo classification process for medical technology received kudos from AdvaMed as did the “Medical Device Patient Safety Act”. ...
FDA-ABIA partnership targets safer, better-performing materials
FDA and Austen BioInnovation Institute in Akron (ABIA) have entered into a groundbreaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices. ...
Legislation to modify FDA mission statement would encourage innovation and protect US jobs
Senator Dan Coats (R-Ind.) has introduced legislation to clarify and reform the mission of FDA in order to promote job creation. The FDA Mission Reform Act (S. 1972) would require FDA to establish a predictable, consistent, and transparent regulatory environment....
Editorial: Polls reflect industry concerns
FDA and to a slightly less extent, AdvaMed, are not effectively representing industry concerns over the 510(k) product review process. The FDA’s CDRH (Center for Devices and Radiological Health) federally funded budget of $272 million should be decreased. And the time and money spent to gain US approvals hurts America in terms of having the latest medical technology available vs. the rest of the world. These are some of the findings of this past year’s MedicalDesign.com Reader Polls....
Industry Viewpoint: A new vehicle for challenging competitors' patents
The intellectual property strategies of medical device companies include not only obtaining and protecting their own rights, but monitoring and challenging the rights of others. ...
ISO watch
Accudynamics (www.accudynamics.com), Lakeville, MA, manufacturer of components for medical and diagnostic equipment, received ISO 9001:2008 recertification for maintaining a quality management system. ...
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