2027, Healthcare and Manufacturing

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2027

Healthcare

Manufacturing

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change. The fate of the PR is far from certain.

Provider

Provider Manufacturing IT Medical

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Manufacturing

Manufacturing Medical Appointment Patient-Centered

Primary Care Digest

Proposed LDT Rule Raises Many Questions but Provides Few Answers

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

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