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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-rinehart , Utah-state-university , Mofo-life-sciences , Laboratory-developed , Public-health-service , Mofo-life , Federal-food , Cosmetics-act , Are-not , System-regulation , Device-reporting , Proposed-rule

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. ....

Australia , Japan , Brazil , Canada , United-states , American , King-spalding , International-standards , European-union , American-national-standards-institute , Drug-administration

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. ....

Netherlands , Pennsylvania , United-states , Dutch , Levin-sedran-berman , Philips-cpaps , Sandy-duggan , Roy-jakobs , Respironics , Us-department-of-justice , Us-district-court , Philips

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. ....

Netherlands , Dutch , Roy-jakobs , Philips-respironics , Us-department-of-justice , Philips , Device-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 ....

University-of-texas , Texas , United-states , Boston , Massachusetts , Fairview , Missouri , State-of-delaware , Delaware , Florida , Zagreb , Grad