FDA Online Tracker Now Accepting Premarket Submissions
Executive Summary
The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.
You may also be interested in...
FDA Preps Device Makers To Use eSTAR For De Novo Requests
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.
Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues
Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.
OTC Sales Of Hearing Aids For Mild To Moderate Loss Allowed Under US FDA Final Rule
After requirement from Congress and push from President Biden, FDA establishes regulatory category for hearing aids to allow US consumers with mild to moderate hearing loss to purchase the devices without a prescription or prior exam.