Device Approval
New Jersey Company Agrees to Halt Production of Unapproved Dental Devices
February 14, 2012 | No comments
The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical …
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EC’s Commissioner for Health and Consumer Policy Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices
February 10, 2012 | No comments
The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the …
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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling
January 20, 2012 | 2 comments
Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA …
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EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination
January 20, 2012 | No comments
New changes are emerging from the French scandal involving breast implants. The European Commission (EC) will investigate whether or not …
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CDRH Issues Draft Guidance on Substantial Equivalence Determinations
January 3, 2012 | No comments
The Center for Device and Radiological Health (CDRH) is the branch of the FDA responsible for managing premarket approval of …
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Overview of Medical Device Approval in Mexico (COFEPRIS Certification)
December 12, 2011 | No comments
Medical device, including IVDs, face the challenge of gaining pre-market clearance in a variety of countries with regulatory frameworks that …
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FDA Offers New Guidance for Artificial Pancreas Device Systems
December 1, 2011 | No comments
The FDA issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes …
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Getting Started with a New Medical Device
November 30, 2011 | No comments
This question often pops-up in a first meeting with clients who have invented a new medical device: do I have …
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FDA Extends Comment Period on 510(k) Guidance
November 14, 2011 | No comments
The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. …
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FDA’s “Off-Label Rule” under Attack
November 7, 2011 | No comments
Medical device and drug manufacturers familiar with the FDA approval process know well the “intended use” statement. Any approval given by the FDA …
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