All posts tagged modification

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The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices.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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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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Deciding When to Submit a 510(k) for a Change to an Existing Device

October 10, 2011 | No comments

I am currently working with a client on a Special 510(k). This is an application to modify the 510(k) on …

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