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Non-Lab Diagnostics: FDA Regulatory Considerations | MoFo Life Sciences

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As.

William rinehartUtah state universityMofo life sciencesLaboratory developedPublic health serviceMofo lifeFederal foodCosmetics actAre notSystem regulationDevice reportingProposed ruleMedical devicesLaboratory developed testsDraft guidanceClinical laboratories

FDA Aligns U S Medical Device Quality System Regulation with International Standards | King & Spalding

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System.

United statesKing spaldingInternational standardsEuropean unionAmerican national standards instituteDrug administrationDevice single audit programQuality system regulationManagement systemQuality management systemDevice regulationProposed ruleDevice quality regulationFederal foodCosmetic actMedical device files

The Philips CPAP recall settlement could be just be the start

The $479 million amount is only a minimum for one of the device industry's most serious recalls, and doesn't cover patient injuries or deaths.

United statesLevin sedran bermanPhilips cpapsSandy dugganRoy jakobsUs department of justiceUs district courtWestern pennsylvaniaLevin sedranDevice reporting

FDA questions Philips replacement respiratory device numbers

The FDA is clarifying Philips claims that it has shipped 2.46 million replacement respiratory devices and repair kits in the U.S.

Roy jakobsPhilips respironicsUs department of justiceDevice reporting

BioSig Technologies : Annual report pursuant to Section 13 and 15(d)

Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases , which amended. | March 31, 2023

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