Due to COVID-19, the sourcing of personal protective equipment (PPE) in the United States has been hampered by the emergence of a so-called ‘wild west’ market. Shortages have prompted the US Food and Drug Administration (FDA) to relax its enforcement policies to help reduce the regulatory hurdles for manufacturers and importers of PPE and medical devices during COVID-19.
This white paper provides manufacturers with practical insights into their legal obligations under both the Federal Food, Drug, & Cosmetic Act (FDC&A) and the National Institute for Occupational Safety and Health (NIOSH) regulations. It also takes a look at the commonalities and differences with the EU system of PPE certification.
Author: Celia Le Lievre, Regulatory Compliance Specialist
Celia is a Regulatory Compliance Specialist with Compliance & Risks. She has a Masters Degree in Maritime Law, a LLM in International Commercial Law and a PhD in the field of renewable energy and environmental protection.
Celia joined Compliance & Risks in January 2020. Her role is focused on conducting extensive legal research and monitoring global regulatory developments impacting the textile and fashion industry. She recently took over the role of Subject Matter Expert for COVID-19, providing clients with regulatory updates and practical insights on their compliance obligations during the state of health emergency.