FDA to institute stricter oversight of home medical devices

Bloomberg News (4/21, Olmos, Larkin) reports, “US regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety of the increasingly popular products, according to information posted” on the FDA’s website. Notably, the “initiative will set new guidelines for home medical device manufacturers, training programs for patients and family members, and labeling and testing standards intended to address use of the devices such as heart monitors and kidney dialysis equipment.” The agency also said that “about 7.6 million people in the US receive healthcare at home from an estimated 17,000 home health companies.” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “Using complex medical devices at home carries unique challenges,” which “may pose environmental or safety hazards that can affect” how these devices function.

CLICK HERE FOR A FREE CONSULTATION

Fill out this form to receive a free initial consultation.

Name

Phone

Email

Message

CALL ME NOW!


Please leave this field empty.

Please leave this field empty.
icon