Get our free email newsletter

FDA Drafts Guidance on Chemical Analysis for Medical Device Biocompatibility

The U.S. Food and Drug Administration (FDA) has issued a draft Guidance that provides additional details on the role of chemical analysis in the biocompatibility assessment of medical devices.

Issued by the FDA in mid-September and published in the Federal Register, the draft Guidance, titled “Chemical Analysis for Biocompatibility Testing of Medical Devices,” describes the recommended methodologies for chemical analysis for biocompatibility assessments.

Chemical analysis is one of several approaches that manufacturers can consider when assessing the overall biocompatibility of a medical device. Chemical analysis can reduce the time needed for biocompatibility testing while also reducing the need for animal testing.

- Partner Content -

Pulse Amplifier Definitions and Terminology

This application note serves as a comprehensive resource, defining key terms like duty cycle, pulse rate, rise/fall time, and pulse width, as well as discussing pulse on/off ratio, RF delay, jitter, and stability.

The FDA’s Guidance on the chemical analysis for biocompatibility assessment of medical devices as published in the Federal Register is available at https://www.federalregister.gov/documents/2024/09/20/2024-21575/chemical-analysis-for-biocompatibility-assessment-of-medical-devices-draft-guidance-for-industry-and.

Comments on the draft Guidance can be files through November 19th on the Federal Rulemaking Portal at https://www.regulations.gov (Reference Docket No. FDA-2024-d-4165).

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.