The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
When the Food and Drug Administration launched its Accreditation Scheme for Conformity Assessment (ASCA) pilot program in September 2020 its central purpose was boosting confidence in the testing results of medical devices.
To that end, the pilot allowed manufacturers to outsource some devices to ASCA-accredited labs to certify they met international standards...
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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.
