FDA’s Catalog of Regulatory Science Tools

by | Aug 27, 2020 | AI, FDA, Medical Devices, Quality, Regulatory

FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a list of regulatory science tools to help the industry in new product development. The Office of Science and Engineering Labs is a part of FDA’s initiative that uses the most innovative science to speed medical device development and patient access to safe and effective medical devices by producing tools to help in the assessment of new medical devices. These tools can be used by the industry to drive innovation and expand the scope to assess emerging medical technologies.1

The list includes phantoms, test methods and computational models and simulations. However, these tools do not replace FDA-recognized standards or qualified medical device development tools since they have not been evaluated for suitability to any specific use.

Tools that are recognized under the Medical Device Development Tools are pre-qualified by the FDA and allows the sponsor to assess their product. This provides for more predictability in the product evaluation by the FDA. The three categories of tools listed in the MDDT are:2

  • Clinical Outcome Assessment: Measures of how a patient feels or functions.
  • Biomarker test: A lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment.
  • Nonclinical assessment model: A nonclinical test method or model that measures or predicts device function or performance in a living organism.

The Office of Science and Engineering Labs hopes to add more to the list once more data is available on the tools and thus expand the program into as many areas as possible.

Do you want to get your medical device to the market? Call us today at 248-987-4497 or email us at info@emmainternational.com.

1FDA (Aug 2020) Catalog of Regulatory Science Tools to Help Assess New Medical Devices retrieved on 08/26/2020 from https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices

2FDA (July 2019) How the FDA Uses Science to Speed Medical Device Innovation retrieved on 08/26/2020 from https://www.fda.gov/news-events/fda-voices/how-fda-uses-science-speed-medical-device-innovation


Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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