Apr 16, 2020
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
Mar 24, 2020
Coronavirus (COVID-19) Update: Daily Roundup
Mar 09, 2020
Dr. Rajamannan Holds Meeting With CDRH Ombudsman Abiy Desta to Review New Evidence of Concealment and Injuries Related to the Testing of FDA Investigational Heart Device
Feb 06, 2020
Syntactx Appoints Dorothy Abel as Vice President, Regulatory Strategy
Dec 17, 2019
5th Annual Medical Device Summit 2020: 2-Day Event (Boston, MA, United States - April 16-17, 2020)
Dec 16, 2019
Two Day Event: Managing Your Complaints & Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection (Tampa, FL, United States - February 6-7, 2020)
Nov 15, 2019
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
Sep 30, 2019
Statement from Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions
Sep 19, 2019
FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
Aug 28, 2019
Two Day Seminar: Managing Your FDA Complaints and Obstacles in Post-Market Requirements (San Diego, United States - September 12-13, 2019)
Jun 21, 2019
Statement from Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, on agency's efforts to increase transparency in medical device reporting
Jun 05, 2019
Two Day FDA Approval Process for Medical Devices Seminar: Gain an Understanding of the Underlying Legal and Regulatory Requirements - London, United Kingdom - September 16-17, 2019
Apr 16, 2019
FDA takes action to protect women's health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
Apr 10, 2019
FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
Mar 27, 2019
Two Day Seminar: Managing Your Complaints and Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection (Newark, NJ, United States - May 16-17, 2019)
Mar 12, 2019
FDAnews Announces -- Post-Market Surveillance: The New World of Compliance, Liability and Best Practices Program on May 16, 2019 in Washington, DC
Mar 07, 2019
FDAnews Announces -- FDA's 2019 Medical Device Regulation Agenda: Are You PreparedWebinar, March 21, 2019
Feb 13, 2019
Dr. Francesca Joseph, Former FDA Medical Officer, Office of Orphan Products Development, Joins NDA Partners
Jan 28, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation
Jan 22, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on latest steps to strengthen FDA's 510(k) program for premarket review of medical devices