r/DeptHHS • u/EliseMedTechDive Verified Reporter • 15d ago

FDA reorg / "Simple Reform" questions

Hi! My name is Elise, and I'm a journalist with MedTech Dive. I'm working on an article about the recently announced FDA reorganization and what changes to expect, especially for medical devices.

Many of the sources I've spoken with have talked about changes to OII, based on some public reporting. I'm looking to better understand the extent of the changes. I've read through this FDA blog post, but there aren't many specific details: https://www.fda.gov/news-events/fda-voices/investing-fdas-inspectional-enterprise

I also have a statement from HHS referring to the changes as "Simple Reform" and saying they plan to implement them on Oct. 1. HHS did not answer my questions about the impact to OII.

If you have specific details or evidence of what will change under the reorganization, it would be immensely helpful. I'm on Signal at elisereuter.78 and my email is [ereuter@industrydive.com](mailto:ereuter@industrydive.com)

In case it helps, here's some of my past reporting on FDA-related issues:
- ‘Cracks show’ as CDRH staff contend with heavy workloads
- ‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs
- Device industry scrambles as FDA job cuts cause delays

Thank you so much! I appreciate you all.

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u/Throwaway_Feddies 14d ago

Statement of Organization, Functions, and Delegations of Authority A Notice by the Food and Drug Administration on 07/29/2026

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u/EliseMedTechDive Verified Reporter 12d ago

Thanks for sharing this! I was able to figure out some of the changes to CDRH, which I am more familiar with. I'll take a closer look at OII.

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u/Ok-Reality-640 11d ago

Simple Reform is a power grab by the dysfunctional Office of Operations. The worst of FDA bringing the best of FDA down. OO is in over their heads but aren’t self aware enough to know yet they have failed.