North America - Nov/Dec 2019
USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...
North America - Nov/Dec 2019
North America - Aug 2019
Drugs - Aug 2019
AAMI/UL 2800 Standard for Medical Device Interoperability recognized by US FDA
North America - Jun 2019
Drugs - Jun 2019
Q-Submission Program (Q-Sub) by FDA
US FDA published Finalized List of Accessories Suitable for Class I
North America - Mar 2019
Drugs - Mar 2019
US FDA statement on Evaluation of Materials in Medical Devices
US FDA releases Modifications to the List of Recognized Standards
Apple obtains last minute De Novo application approval: Just in time for the Apple Watch 4 reveal
US FDA introduces cyber-security considerations for Tier 1 & 2 Devices and clarifies CBOM import
North America - Dec 2018
Drug - Dec 2018
US FDA Special 510(k) Program Pilot
North America - Aug/Sep 2018
Drugs - Aug/Sep 2018
Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US