Since the beginning of the COVID-19 pandemic, the United States Food and Drug Administration (“FDA”) has issued more than eighty (80) guidance documents describing flexibilities that would be available to manufacturers of medical devices, drugs and biological products, and foods during the public health emergency. Several of these guidance documents have been modified, updated, or
… a major change to the Regulation is needed to prevent shortages of life-saving medical devices…
Background
On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella Kyriakides, a major change to
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning. Similarly, creating an impression of approval of a device establishment or its devices because the establishment is registered with FDA also is
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a full suite of health care services, including telehealth visits, prescribing, pharmacy dispensing, and counseling services, while others are focused on more niche areas
On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days after the end of the designated public
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated to stay home across the country. Prior to the COVID-19 PHE, approximately 12,5000 Medicare beneficiaries received telehealth services and only 106 telehealth services were reimbursable.
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for transitioning the multitude of devices
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that technological advances “have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals” and that “DHTs [ ] are playing a growing role
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016. For full text of the bill, click here. The 21st Century Cures Act included a variety of measures seeking to accelerate medical
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) released a report in September 2021 that found many state Medicaid programs do not sufficiently evaluate