US FDA Lists Hundreds Of Devices For 510(k) Exemption

A list of devices being considered for 510(k) exemption includes allergens used in immune system testing, drug tests for employers and denture supplies. The agency is collecting comments through May 15.

Manufacturers won’t need to submit 510(k)s on devices ranging from surgical lamps to tests used to screen employees for drug use if a March 13 proposal from US FDA goes into effect.

The Federal Register notice lists several hundred device "Code of Federal Regulation" categories and a total of...

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Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

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HHS Suggests Drastic Reductions To Skin Substitute Payments

 
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From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

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HHS Suggests Drastic Reductions To Skin Substitute Payments

 
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The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.