Most of these cuts were new people on probation so I think we will be fine. Might it slow things down compared to previous, maybe, maybe not. There are still a significant amount of staff who work in the department that will look after our submission.
From Chatgpt so take what you will...
As of 2024, the FDA's Center for Devices and Radiological Health (CDRH) employs approximately 2,260 staff members. This represents an increase from 2,230 employees in 2023. The CDRH is responsible for ensuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and radiation-emitting products.
In 2024, FDA authorized:
- 3,107 510(k)s
- 48 Emergency Use Authorizations (EUAs) (one related to Middle East Respiratory Syndrome Coronavirus [MERS-CoV], four related to Monkeypox/mpox, and 43 related to COVID-19)
- 47 De Novo reclassification requests (de novos)
- 33 Premarket Applications (PMAs) plus 2,217 PMA supplements
- 4 Humanitarian Device Exemptions (HDEs) plus 108 HDE supplements
(20min delay)