FDA Law

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. See our prior blog post on the topic here. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management.

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Management Manufacturing Medical IT 115

FDA Law

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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Management Manufacturing Supply Chain Provider 45

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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Clinic Medical Provider Patients 52

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

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Consulting Manufacturing Utilities Provider 52

FDA Law

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. FDAs policy has prohibited the simultaneous prescription and OTC marketing of the same drug product under the same conditions of use unless there is a clinically meaningful difference between them.

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Provider Healthcare Individual Manufacturing 59