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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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 ...

Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...

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 ...

Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. Explore the top mobile IV therapy companies boosting immune health on demand ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.” The FDA sent three warning letters to ...

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 ...

UPPER SAUCON, TWP., Pa.- Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its medical scopes. Late last month, the FDA announced it ...