Tag Archives: personal protective equipment

New Exemptions to FEMA Rule Make It Easier to Export Covered PPE in Certain Situations

On April 21, 2020, the Federal Emergency Management Agency (FEMA) published a notice that establishes a number of exemptions to the rule issued earlier in the month that generally prohibited the exportation of various kinds of essential medical products without FEMA’s approval. These new exemptions make it easier to export the covered medical products under certain circumstances, although several of the exemptions require that a special letter of attestation be submitted to FEMA before the goods can be exported from the United States.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

To read the full text of this Duane Morris Alert, please visit the firm website.

3D Printing of PPE and Other Medical Devices

During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.

For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.

To read the full text of the article by Duane Morris , visit the MD+DI website.

FEMA Approval Required for Export of Certain Personal Protective Equipment

As of April 10, 2020, Federal Emergency Management Agency (FEMA) approval will generally be required for the export of certain kinds of personal protective equipment (PPE) from the United States, pursuant to a FEMA temporary final rule.

To read the full text of this Duane Morris Alert, which discusses the parameters and procedures established by the temporary final rule and their implications for U.S. and foreign entities, please visit the firm website.

CARES ACT Creates New Opportunities for Companies That Can Supply PPE and Other Essential Medical Products

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief and Economic Security Act (CARES Act) into law. The CARES Act will provide federal agencies with nearly $100 billion to address the supply chain breakdowns in medical products needed to combat the COVID-19 pandemic. The rapid influx of funding creates new opportunities for companies that can manufacture or supply essential personal protective equipment (PPE) and other key medical products.

To read the full text of this Duane Morris Alert, please visit the firm website.