News & Analysis as of

Medical Devices Masks

Parker Poe Adams & Bernstein LLP

OSHA Proposes Eliminating Medical Evaluation Requirement for Some Respirators

As part of its deregulatory initiative on July 1, the federal Occupational Safety and Health Administration proposed deleting requirements for medical evaluations before employees are permitted to use certain classes of...more

Knobbe Martens

Researchers Develop Face Mask for Detection of SARS-CoV-2

Knobbe Martens on

According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath.  Instead of relying on a lab, the...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - June 2020: Safety First - Describing Personal Protective Equipment for Proper Classification

As of June 11, 2020, the USPTO’s Official Manual of Acceptable Identifications (ID Manual) has been revised to add, re-classify, and clarify existing entries for personal protective equipment such as masks and gloves....more

Womble Bond Dickinson

Face Masks – Liability Considerations for Manufacturers and Sellers

Womble Bond Dickinson on

The Centers for Disease and Control and Prevention (CDC) is now recommending that the general public wear face masks to help slow the spread of COVID-19. Along with this recommendation, many businesses, individuals, and other...more

Mintz - Health Care Viewpoints

FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators

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

Seyfarth Shaw LLP

Head to Toe: Summary of FDA COVID-19 Guidance Relating to Gowns, Other Apparel, and Gloves

Seyfarth Shaw LLP on

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

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