Wayne Matelski on Medical Devices

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

10/25/2023 / Affordable Care Act , CLIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Medicare , Premarket Approval Applications , Proposed Legislation , Proposed Rules , Regulatory Oversight

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This draft guidance is one of...more

9/12/2023 / Best Practices , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Public Domain , Safety Standards

EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy. From...more

10/12/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Public Readiness and Emergency Preparedness Act (PREP Act)

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices. In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more

3/31/2020 / Best Practices , Coronavirus/COVID-19 , Emergency Management Plans , Health and Safety , Infectious Diseases , Medical Devices , Policies and Procedures , Public Health , Risk Management , Workplace Safety

Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic

FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues. This Guidance takes effect immediately and applies to postmarketing...more

3/25/2020 / Adverse Events , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry

Wayne Matelski

ArentFox Schiff

Popular Topics by This Author

Latest Posts › Medical Devices

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic

Wayne Matelski

ArentFox Schiff

Popular Topics by This Author

Latest Posts › Medical Devices

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA

FDA Loosens Requirements for Sterilizers, Disinfectant Devices, and Air Purifiers

Delay in Reporting Adverse Event Reports for FDA-Regulated Products During the Pandemic

"My best business intelligence, in one easy email…"