Regulatory & Compliance Perspectives

  1. 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.

  2. 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.

  3. 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.

  4. Pharma's Data Secret That Medical Device Companies Should Adopt 9/12/2024

    The pharma industry has invested greatly in IT systems and optimized data and content management. Medical device companies can learn from pharma's experience — and it will ease the regulatory burden.

  5. How Chile Is Shaping Medical Device Clinical Trials In Latin America 9/11/2024

    Chile's robust healthcare infrastructure and fast regulatory approval timeline have positioned it as an attractive destination for medtech companies seeking to conduct early feasibility clinical research. 

  6. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

  7. The Learned Intermediary Doctrine Sees Curious Change In California 8/5/2024

    U.S. courts have long recognized the learned intermediary doctrine, which holds that a manufacturer of a prescription medication or medical device discharges its duty to warn by providing an adequate warning to the doctor. In the recent Himes v. Somatics, LLC, the California Supreme Court may have opened the door to this argument. 

  8. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

  9. How Early Talks With The FDA Can Pave Your DTx Approval Pathway 7/22/2024

    Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

  10. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.