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FDA and CMS Have Formed a Joint Task Force for LDT Co-Regulation

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FDA and CMS have just announced that the agencies are forming a joint task force to explore “areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories.” This is a laudable effort that should ensure a minimum of overlapping regulation.

FDA has played a central role throughout the announcement and discussion of its proposal for LDT regulation, and it is good to see that it is now publicly bringing CMS into the discussion.

The announcement was made in a post on the FDA blog that was co-authored by Jeffrey Shuren, M.D., J.D. from FDA and Patrick Conway, M.D., MSc from CMS.

Presumably this announcement means that LDT developers can expect even more delay before FDA implements its regulatory framework.