Tuesday 20 February 2018

All posts tagged Special 510(k)

CDRH Issues Draft Guidance on Substantial Equivalence Determinations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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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The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices.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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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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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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FDA Forms Expert Panel to Speed up Device Approval

October 5, 2011 | No comments

Reuters is reporting on the FDA’s announcement yesterday seeking public input on a plan to create a network of outside experts who would […]

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