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# ‘Burdensome’ Device Assessment Guidance: Post
- URL: https://www.fdaweb.com/burdensome-device-assessment-guidance-post/
- Published: 2024-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:47:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158240

While an FDA draft guidance on chemical analysis for biocompatibility assessment of medical devices is a “step in the right direction,” additional guidance is needed to address some of its “burdensome” recommendations. That’s the view of **Adrienne Lenz**, the principal medical device regulation expert at Hyman, Phelps & McNamara, and regulatory and biological safety consultant **Kristy Katzenmeyer-Pleuss**.

Writing in the law firm’s *FDA Law Blog*, the two [say](https://us6.campaign-archive.com/?e=bde275f02e&u=192e2d8712a743737ce3d003b&id=a55d5f6b03&ref=fdaweb.com) additional guidance is needed in the related areas of simulated use and release kinetics studies. “In order to be more helpful to industry, reasonable recommendations to reduce animal testing in practice, rather than in theory, are still needed,” they say.

The draft describes chemical characterization methods that may be used to demonstrate the biocompatibility of a medical device as an alternative to conducting biological testing. “Chemical characterization identifies and quantifies chemicals that may be released from the medical device,” Lenz and Katzenmeyer-Pleuss write, “while a toxicological risk analysis evaluates the risks to the patient associated with the chemicals identified.”

Although the draft suggests chemical characterization can save companies time in some instances, the two experts say it will “rarely save sponsors time or money to use chemical characterization in place of biological testing for most limited and prolonged contact devices to support FDA premarket submission.”

The post discusses five topics from the draft that the authors consider to be burdensome and likely areas for FDA scrutiny of a sponsor’s chemical characterization data.

The authors recommend filing a Pre-Submission with FDA when considering a chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.