The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.
FDA’s device center will issue a draft guidance document next month to assist companies in using soon-to-be-released global unique device identifier database.
The global UDI database is an integral component of CDRH’s developing UDI program, which was outlined in a proposed rule...
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MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.
European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.
The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.
The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.
Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.
European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
