August 11, 2020 By Nancy Crotti

Exceeding regulatory requirements: Beyond the checklist

August 11, 2020 By Nancy Crotti

Hologic applies for pooled COVID-19 testing nod

August 10, 2020 By Nancy Crotti

FDA opens umbrella authorization for surgical masks

July 30, 2020 By Nancy Crotti

Dems seek to force EPA action on ethylene oxide monitoring

July 27, 2020 By Nancy Crotti

LabCorp COVID-19 test may be used on asymptomatic people

July 24, 2020 By Tom Salemi

DTWeekly: Can Drawbridge, Edwards bring disruptive innovation to blood-draw, heart-surgery industries?

July 10, 2020 By Chris Newmarker

FDA plans to resume onsite inspections later this month

July 2, 2020 By Nancy Crotti

Report: Haemonetics’ blood-collection devices could leave particles in donors

July 2, 2020 By Sean Whooley

Spinal Elements’ cervical fixation system wins FDA nod

July 2, 2020 By Danielle Kirsh

How COVID-19 impacts FDA interactions with medical device manufacturers

July 1, 2020 By Nancy Crotti

FDA gives certain device makers more time to add UDIs

June 23, 2020 By Nancy Crotti

FDA extends switch to virtual meetings, warns it may miss some deadlines

June 22, 2020 By Nancy Crotti

Hahn says FDA will keep some COVID-19-era changes in place

June 18, 2020 By Danielle Kirsh

China issues new procedures for medical device registration

June 16, 2020 By Danielle Kirsh

How EU MDR and human factors affect design user-friendly software user interfaces

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