The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a ...

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The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...

The FDA halted the manufacture of Medtronic's ($MDT) SynchroMed II Implantable Infusion Pump Systems, citing repeatedly failing to correct violations of the agency's ...

FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests ...

The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements. The agency cautioned ...

When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...