REU Associates Inc. will develop your regulatory submission strategy and implement your regulatory submission activities pertaining to Premarket Notifications – 510(k), Premarket Approval Applications - PMAA, Investigational Device Exemptions – IDE, Request for Product Classification – 513(g), and facility registration and device listing.
We will write and submit to FDA, on your behalf, the pertinent regulatory submissions which address your business requirements.
510(k) – Determine which is most appropriate for your business:
PMAA (Premarket Approval Applications)
- PDP (Product Development Protocol)
IDE (Investigational Device Exemptions)