Science and Engineering Laboratories: Updates from FDA CDRH

Science and Engineering Laboratories

The FDA’s Office of Science and Engineering Laboratories (OSEL) works to promote the innovation and development of new lifesaving medical devices. Their goal is to use the latest science to expedite the development of medical devices. The FDA would like to bring awareness to the 20 research programs that are in place for the advancement of physical, life, and engineering sciences. A list of the programs can be viewed in the OSEL section of the FDA website.

Another useful program is the Office of Science and Engineering Laboratory’s Catalog of Regulatory Science Tools, where a variety of regulatory science tools is collated as they become available. OSEL updates this list with articles and references in order to facilitate the development and assessment of emerging technologies. They do not replace relevant standards, but are intended to serve as helpful tools . The catalog can be viewed in the OSEL section of the FDA website.

The FDA also just launched an online Biocompatibility Resource Center that includes step-by-step recommendations compiled from existing FDA guidance for use while preparing medical device submissions for the FDA. This looks to be a helpful resource that should prove helpful to medical device companies. It can be found in the Premarket submissions section of the FDA website.

Read our post on risk analysis of tools:  Risk Analysis/FMEA/FTA software tools

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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