INSIGHTS

News & Information about FDA Compliance

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...

FDA Publishes Final Refuse To Accept Guidance

Final Guidance Documents: When to submit new 510(k)s for devices and software

GDUFA REAUTHORIZED FOR 2018

U.S. FDA ANNOUNCES FY2018 USER FEES

FDA Publishes Final Refuse To Accept Guidance

Final Guidance Documents: When to submit new 510(k)s for devices and software

GDUFA REAUTHORIZED FOR 2018

U.S. FDA ANNOUNCES FY2018 USER FEES