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# Help Industry with ‘Bad Labs’: Post
- URL: https://www.fdaweb.com/help-industry-with-bad-labs-post/
- Published: 2024-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:25:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156525

Hyman, Phelps & McNamara principal medical device regulation expert **Adrienne Lenz** and attorney **Allyson Mullen** say FDA should follow its 2/20 [letter](https://www.fdaweb.com/vet-third-party-device-data-fda/) to the medical device industry urging companies to be aware of issues with fraudulent laboratory data with “practical guidance to help firms establish and maintain data integrity across the total product lifecycle.” In a post on their company’s *FDA Law Blog*, Lenz and Mullen [say](https://www.thefdalawblog.com/2024/03/bad-labs-bad-labs-whatcha-gonna-do/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=bad-labs-bad-labs-whatcha-gonna-do) the agency letter provided little information to guide industry conduct. “While the title of the letter refers to ‘fraudulent’ data,’” they write, “the rest of the letter does not explain the nature of the allegedly fraudulent activities that could assist industry in identifying bad labs.”

Lenz and Mullen say FDA must be transparent with industry as to how the issue will be handled for pending and cleared submissions.

“The sponsors are almost always victims that had no intention to deceive the agency,” they conclude. “Unless or until FDA can provide actionable guidance on how to avoid being deceived and/or how to manage the issue, if it is uncovered, we urge FDA to give sponsors the benefit of the doubt and work with them to resolve the issue.”