2023 Manufacturing Patients Specialization 
FDA Law Blog
APRIL 25, 2023
Shapiro — Does your firm manufacture a “cyber device”? This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. By Philip Won & Jeffrey K.
FDA Law Blog
MAY 8, 2023
The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.
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FDA Law Blog
MAY 19, 2023
In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.
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. 150,000).”
Physician's Weekly
JUNE 19, 2025
About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. Dan: Another addition: Manufacturer coupons.
FDA Law Blog
APRIL 8, 2024
For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”
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