Device Approval
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The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices.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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Six Mistakes That Will Delay Your FDA 510k Submission
October 31, 2011 | No comments
In July 2011, the FDA conducted an analysis of its 510(k) data to determine the causes of increasing medical device …
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Mobile Medical Apps
October 26, 2011 | No comments
The FDA issued draft guidelines on mobile medical apps. Developers will likely complain that the FDA guidelines will make it …
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Medical Device Pre-Market Programs: An Overview of FDA Actions
October 20, 2011 | No comments
Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized the need to re-evaluate and modernize …
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Color Additives and Contact Lenses (Item II)
October 13, 2011 | No comments
It is hard to find a contact lens on the market that is not offered tinted. Manufacturers apply for a …
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Medical Devices Get Parallel Review Pilot From FDA and CMS
October 11, 2011 | No comments
Those creating medical devices often discover after putting all their energy into getting FDA approval that Medicare coverage doesn’t automatically …
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