FDA Announced Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank



Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.

Sandra “SAM” Sather Speaking at MCC Summit Nov. 14-15


Join with subject matter experts and learn what really matters in clinical trial performance metrics in the first ever Metrics Champion Consortium (MCC) Summit. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis. Understand if your staff has adequate critical thinking skills to evaluate risk and take appropriate action. Identify effective performance management using Gilbert’s Behavioral Engineering Model (BEM) in Clinical Research. Discover answers to key questions while delving into case scenarios with speakers and other attendees during the interactive session.

FDA Announced Draft Guidance: The Special 510(k) Program


Key Takeaways:

  • The Special 510(k) Program is an alternate pathway for premarket notifications.

    • It was originally established in 1998.

    • It allows manufacturers to declare that a modification to their own device cleared under 510(k) still conforms to design controls.

  • Currently, if a manufacturer modifies its own marketed device and changes the indication for use or creates technological differences, the application must be submitted as a traditional 510(k).

FDA Releases Guidance on Benefit-Risk Factors in Substantial Equivalence in 510(k) Submissions


A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.