Theodore Lis on Medical Devices

FDA Draft Guidance: Remote Data Acquisition in Clinical Investigations

In December 2021, FDA issued draft guidance, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, which provides guidance for clinical trial sponsors, investigators and other interested...more

3/11/2022 / Clinical Trials , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA Inspection Readiness During the Pandemic

Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more

2/1/2022 / CGMP , Food and Drug Administration (FDA) , Inspections , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more

6/24/2020 / Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Imports , Medical Devices , Medical Equipment , NIOSH

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more

6/24/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , NIOSH , Personal Protective Equipment

FDA Releases Guidance Requiring Notification of Certain Medical Device Shortages Related to COVID-19 Testing and Treatment

Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed...more

5/12/2020 / CARES Act , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies

FDA Revises EUA Criteria for Respirators Manufactured in China

In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators...more

5/12/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices

FDA Issues Guidance Regarding Modifications to Certain Cleared Infusion Pumps During COVID-19 Public Health Emergency

On April 5, 2020, the U.S. Food and Drug Administration (FDA) issued guidance about its “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...more

4/10/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

FDA Expands Use of Certain Non-Cleared Electronic Thermometers During COVID-19 Public Health Emergency

On April 4, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance on “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...more

4/9/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

FDA Eases Regulations On Face Masks And Respirators During COVID-19 Pandemic

On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more

4/1/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more

3/31/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Suppliers , Supply Chain

Theodore Lis

Faegre Drinker Biddle & Reath LLP

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