June 15, 2023
Dear Community: There's a Final FDA Guidance on Premarket Submissions for SaMD and SiMDThe final version is a significant improvement to the 2005 version.
FDA News
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B & A Blogs
Insights on Law, Regulatory Affairs, & Quality Assurance
The team discusses fundamentals and contemporary issues shaping our areas of practice.
June 7, 2023
Dear Community: The FDA is Taking Enforcement Action for NoncomplianceThis should be a major warning to Medical Device manufacturers, especially SaMD and Digital Therapeutics developers.
Insights
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June 1, 2023
FDA Enforcement Action to Synovo Production, Inc.The FDA cites failure to obtain a new market authorization and failure to document aspects of the Quality System.
Insights
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May 4, 2023
Dozens of FDA COVID-19-Related Guidances Will Soon No Longer Be in Effect. Are You Ready? The FDA issued an Enforcement Transition Guidance, describing their plan to transition from certain COVID-19 era enforcement policies back to “normal operations.”
FDA News
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April 4, 2023
Draft FDA Guidance on the Change Control Plan for AI/ML-Enabled Medical DevicesThere's a lot of detail to consider in this guidance.
FDA News
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March 31, 2023
FDA Guidance on Cybersecurity in Premarket SubmissionsIf you haven't integrated cybersecurity into your quality and regulatory activities, it's time.
FDA News
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October 3, 2022
The FDA’s Ever-Evolving and Increasingly Complex Framework for the Regulation of SaMD—Analysis of the Final CDS Software GuidanceThe new policy requires a highly subjective, case-by-case analysis. Industry needs to retrategize.
Thought Leadership
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November 8, 2021
Summary and Analysis of the FDA’s Proposed Updates to the Guidance on Premarket Submissions for Software Device FunctionsThe FDA's draft guidance, Content of Premarket Submissions for Device Software Functions, has some notable differences from the current guidance.
FDA News
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May 21, 2018
Digital Health's Disruption of FDA Regulatory PolicyDigital health innovation is driving the FDA to change regulatory policy for drugs, biologics, medical devices, and combination products. Stakeholders should pay attention.
FDA News
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