Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.
Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.
To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.
In the Federal Register posted on August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published proposed regulations that, if finalized, would expand the Open Payments reporting requirements initially introduced under the Physician Payments Sunshine Act. The Open Payments program sheds light on some of the payments (and other transfers of value) made from certain drug, device, biologicals and medical supply manufacturers to covered recipient physicians and teaching hospitals. Under the Physician Payments Sunshine Act, the applicable manufacturers must report certain payments made to the covered recipients through the Open Payments program on an annual basis. Such disclosures are available to the public. The categories of payments or transfers of value that must be disclosed include: research, honoraria, gifts, grants, travel expenses, and marketing, education or research for a specific covered drug or device.
View the full Alert on the Duane Morris LLP website.
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
Read the full text of this Alert on the Duane Morris LLP website.