Deborah Shelton

Deborah Shelton

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Purple Means DNR: FDA Issues Letter to Medical Device Manufacturers on Color-Coded Wristbands

Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that...more

8/19/2021  /  American Health Care Act (AHCA) , Do Not Resuscitate (DNR) , Food and Drug Administration (FDA) , Manufacturer Liability , Manufacturers , Medical Devices

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more

4/21/2021  /  21st Century Cures Act , Device Classification , Final Rules , Food and Drug Administration (FDA) , Medical Device Data System , Medical Devices , Software

FDA Issues Enforcement Policy for Telethermographic Systems During COVID-19

FDA continues at a relatively fast clip to issue policies intended to help solve a dire problem: the ongoing need to expand the availability of certain medical products in the US that are critical to addressing the COVID-19...more

4/23/2020  /  510(k) RTA , Coronavirus/COVID-19 , Enforcement Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

Update: Importation and Distribution of Face Masks and Respirators During the COVID-19 Pandemic

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic. As reported in the news on a...more

4/6/2020  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Personal Protective Equipment

FDA Issues Enforcement Policy for Ventilators and Other Respirators

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more

3/31/2020  /  Coronavirus/COVID-19 , Enforcement , Food and Drug Administration (FDA) , Health and Safety , Infectious Diseases , Medical Devices , Policies and Procedures , Public Health , Risk Management , Workplace Safety

The Importation of Personal Protective Equipment for Treatment of COVID-19

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system. Masks, ventilators, and gowns are...more

3/25/2020  /  Coronavirus/COVID-19 , Customs and Border Protection , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment
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