United States: New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Hyman, Phelps, & McNamara, P.C.

Mondaq

23 Oct 2023 0 shares 1 views

United States: New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Hyman, Phelps, & McNamara, P.C.

Mondaq

Published 23 Oct 2023

On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...

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United States: FDA's New Draft Guidance On 510(k) Implant Devices: What You Need To Know - Hyman, Phelps, & McNamara, P.C.

As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and..

Mondaq 26 Oct 2023

United States: From GRP To SIUU – The Evolution Of FDA Guidance On Off-Label Dissemination Of Scientific Information - Hyman, Phelps, & McNamara, P.C.

Yesterday, FDA published a new Draft Guidance, "Communications from Firms to Health Care Providers Regarding Scientific Information..

Mondaq 25 Oct 2023

United States: New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Hyman, Phelps, & McNamara, P.C.

United States: New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Hyman, Phelps, & McNamara, P.C.

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