Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
On December 31, 2020, the Federal Emergency Management Agency (“FEMA”) published a temporary final rule again extending and modifying export restrictions on scarce and critical health and medical supplies. The new rule...more
Eight months into the coronavirus (“COVID-19”) pandemic and employers in both healthcare and non-healthcare settings are grappling with requirements for employees’ use of personal protective equipment (“PPE”) and respiratory...more
- Legislation to bolster the U.S. supply chain for medical equipment becomes an issue of bipartisan focus in Congress. - Differing proposals included in the House and Senate “Phase 4” COVID-relief proposals as well...more
Report on Supply Chain Compliance 3, no. 13 (June 25, 2020): Chinese auto manufacturer BYD Auto Co. Ltd. received approval from the United States National Institute for Occupational Safety and Health (NIOSH) to sell U.S....more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more
The COVID-19 pandemic has had profound economic and political effects over the past several months. Increasingly, those effects have led a number of US policymakers, US allies, and others to question certain US sanctions...more
In response to shortages of Personal Protective Equipment (PPE) critical to limiting the spread of and mitigating the impact of COVID-19, the United States has recently issued a series of rules, memoranda, and other guidance...more
As concern about availability of personal protective equipment (“PPE”) continues to grow amid the COVID-19 pandemic, the federal government continues to take action aimed at increasing the availability of PPE with important...more
In response to widespread shortages of protective masks, face shields and other medical devices and device components (e.g., ventilators and ventilator parts) in light of COVID-19, some colleges and universities with the...more
The Federal Emergency Management Agency (FEMA) issued temporary final regulations (FEMA Regulations or Regulations), effective from April 7, 2020 until August 10, 2020, to prohibit exports without FEMA’s explicit approval of...more
The United States Department of Labor’s Occupational Safety and Health Administration (OSHA) ensures safe and healthful working conditions for employees by setting and enforcing standards and by providing training, outreach,...more
Along with the US Food and Drug Administration’s guidance addressing shortages of masks and respirators, FDA has released guidance aimed at increasing the supply of other personal protective equipment important in the fight...more
Foley Hoag’s Trade Sanctions & Export Controls Practice offers experienced, proactive regulatory advice to help clients avoid regulatory compliance missteps and to prevail in official proceedings… Included in this Issue: •...more
To address the COVID-19 public health crisis, FDA issued two immediately in effect guidance documents: FDA Guidance for Industry (April 2020) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more