FDA Publishes Final Refuse To Accept Guidance
Today, FDA released the final version of its guidance document, relating to its Refuse to Accept (RTA) policy. The document, “Refuse to...
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....
GDUFA REAUTHORIZED FOR 2018
On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization...
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...
