Device Approval
EU Looks to Tighten Medical Device Safety With Implant Registry
April 30, 2012 | No comments
In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip …
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Senators Seek to Improve Safety of Children’s Medications and Medical Devices
April 18, 2012 | No comments
A bipartisan team of Senators announced today new legislation aimed at improving the safety of children’s medications and medical devices. The bill introduced today …
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New FDA Guidance on Considerations Used in Device Approval, De Novo Decisions
March 28, 2012 | No comments
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of …
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Medside Interview – Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?
March 18, 2012 | No comments
Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US? [ 43:02 ] Play Now | Play in Popup | Download (47)If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment …
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Guest Editorial: How Chinese Medical Device Manufacturers are Entering Western Markets
February 28, 2012 | 2 comments
How Chinese Medical Device Manufacturers are entering Western Markets Guest Editorial: Dr. Camilla Storaa The Chinese economy has grown to be …
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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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