Final Guidance Documents: When to submit new 510(k)s for devices and software
FDA has issued final guidance documents to help medical device companies determine when to submit new 510(k)s for hardware and software....
U.S. FDA ANNOUNCES FY2018 USER FEES
The #USFDA just announced its #UserFees for FY2018, and there are some MAJOR increases. If your company is planning to submit a 510(k) or...
