USA – FDA releases three post-pilot ASCA draft guidances
The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment...
International – The global regulatory landscape for AI/ML-enabled medical devices
Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in...
International – Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
Europe – Notification of a Body in the framework of a technical harmonization directive
Body Name
ISTITUTO SUPERIORE DI SANITA'
Address
Viale Regina Elena, 299
00161 - ROMA
Country
Italy
Phone
+39 06 49906146
Fax
+39 06 49903150
Email
roberta.marcoaldi@iss.it
Website
www.iss.it
Body Number
0373
Last approval date
03/05/2016...
USA – FDA Authorizes First Over-the-Counter Hearing Aid Software
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with...
USA – Industry groups call for changes to FDA’s guidance on use-related risk analyses
Stakeholders want the US Food and Drug Administration (FDA) to provide more clarity on its expectations for use-related risk analyses (URRA) for “stand-alone” non-combination...
Canada – The evolution of Canada’s medical device regulatory framework
The evolution of the medical device regulatory framework in Canada is not as well understood as those of other major jurisdictions such as the...
USA – FDA updates patient preference guidance to span the product life cycle
The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient...
Europe – EU Update: Current State of Medical Device Regulations
Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED
Regulation 2024/1860 was officially released to extend the transition time for legacy...
International – IMDRF Document Implementation Report – Final document
This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on...
