The U.S. Food and Drug Administration on Friday released draft guidance on a wide ranging list of medical devices--many of which fall into the mobile healthcare spectrum--which the agency believes do not require premarket notification review for safety and effectiveness.
The list includes thermometers; stethoscopes; talking first aid kits; ear, nose and throat devices; general and hospital use devices; ophthalmic devices; endoscopic light; fertility diagnostic devices; and exercise equipment.
"The FDA believes devices identified ... are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness," the guidance states. "FDA intends to propose exempting these devices from premarket notification."
The guidance arrives as debate regarding mHealth device and app regulatory oversight continues between federal agencies, lawmakers and industry advocacy groups.
"This is big news, and a huge boost to the mHealth industry," health attorney Brad Thompson of Epstein Becker Green, tells FierceMobileHealthcare in an email. Thompson represents five groups on the matter, including the CDS Coalition, the CDS Consortium, the Continua Health Alliance, the mHealth Regulatory Coalition and the Wireless-Life Sciences Alliance.
"It shows that FDA is being extremely practical in reviewing its own practices, and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources," Thompson says. "My hat is off to FDA."
In June, FDA published draft guidance for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements. The guidance allows MDDS developers to focus on improving interoperability with other medical devices, according to Bakul Patel, senior policy adviser to the director of the Center for Devices and Radiological Health at FDA.
Mobile healthcare device vendors are paying close attention to FDA guidance and other regulatory proposals as they prep and launch tools in the market in rapid fashion, and are striving to be part of the decision-making process. For instance, Apple, in December, met with the FDA to discuss regulatory oversight.
For more information:
- read the FDA draft guidance document (.pdf)
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