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A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity from the accredited lab as part of a premarket submission to the FDA. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s medical device, drug evaluation, and biologics evaluation centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
The FDA clarified in new proposed rule how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More
TGA has authorized the supply of five products registered overseas that are similar in strength to the Australian patches, but they are also facing delays. Read More
Certificates issued by EEA-based Notified Bodies — the independent organizations that award certifications such as the CE mark — will continue to be valid in the UK until June 30, 2023. Read More
The FDA spelled out best practices for the use of patient-reported outcome (PRO) instruments in the development, evaluation, and surveillance of medical devices, in a newly released draft guidance. Read More