Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
In response to the COVID-19 outbreak, and the need to quickly develop medical products and services to fight the virus, the United States Patent and Trademark Office (“USPTO”) is allowing the trademark examination process for...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
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
At the same time as the Federal Communications Commission (“FCC”) adopted final rules to establish a multi-year telehealth pilot program entitled the “Connected Care Pilot Program,” the commission released a Report and Order,...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
Recently, health care providers – in particular hospitals – have been requested by the federal government to share data related to the treatment of COVID-19 (coronavirus) patients and have been ordered by the Ohio Department...more
In April 2017, the EU has revised the regulatory framework for medical devices and in vitro medical devices in the EU. The package, which includes regulation (EU) 2017/745 on medical devices (Medical Device Regulation or MDR)...more