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Devicemakers need to consider the primary audience for the sections of the premarket approval (PMA) application that receive the most FDA scrutiny to facilitate a more focused, orderly and timely review by the agency.
Independent third-party inspections could begin next month, and if the program is successful, the FDA will resume full-scale facility inspections, according to David Feigal, director of the Center for Devices and Radiological Health.
The FDA is withholding final approval of Staar Surgical’s premarket approval application (PMA) for its implantable contact lens (ICL) while the company implements better procedures for filing medical device reports (MDRs).
The FDA's 11-year ban on silicone breast implants will continue under stricter approval guidelines on safety and effectiveness, which were developed, in part, in response to data submitted by Inamed.
Eli Lilly has resolved FDA concerns about current GMP issues at its Indianapolis facilities, where it plans to manufacture the antidepressant Cymbalta and injectable schizophrenia drug Zyprexa, the company announced recently.
Devicemakers need to conduct authenticity checks on all electronic records and submissions to ensure that the program being used is compliant with 21 CFR Part 11 and all predicate rule requirements, according to a leading Part 11 expert.
The FDA is giving a dental laboratory in Costa Rica a final chance to correct several quality system violations cited during a recent inspection before taking further regulatory action.
The Centers for Medicare & Medicaid Services (CMS) is implementing several changes to the national coverage determination (NCD) process called for under the landmark Medicare Rx Act, which was signed into law Dec. 8.