Regulatory & Compliance Perspectives

  1. Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions 12/9/2024

    In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

  2. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

    FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

  3. A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests 12/3/2024

    Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with regard to medical device regulations that would otherwise apply to labs that prepare and/or market LDTs. 

  4. How The EU AI Act Impacts Medical Device Manufacturers 11/18/2024

    The EU AI Act is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries. Here's how it impacts medical device manufacturers.

  5. We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead 11/13/2024

    The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.

  6. AI-Enabled Medical Device Manufacturers: Are You Prepared for Evolving FDA Oversight? 11/1/2024

    As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges, as well as evolving safety and compliance risks.

  7. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

    The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

  8. The ABCs Of PCCPs (Predetermined Change Control Plans) 10/10/2024

    The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.

  9. Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices 10/7/2024

    The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.

  10. Your 510(k) Hasn't Sailed Through. Now What? 9/24/2024

    Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? How can a Q-Sub help? This article shares practical recommendations.