Former FDA OII Staff - Reorg Details Impacting Device Oversight

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 [email redacted] 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.