Even though the FDA recently began an open dialog with the wireless medical device community over mHealth regulation, enforcement of federal quality regulations at labs that develop medical devices has been scaled back by the FDA, according to a recent report by the Project on Government Oversight. FDA inspections of "good laboratory practices" at facilities that do early testing of medical devices like pacemakers, stents and imaging machines fell from 33 in 2005, to seven in 2007, to one last year. There are none planned for 2009.
"The decision ... to not enforce [lab standards] is stunning in its contempt for the protection of patients," the independent group said in its report.
The FDA says it will focus on enforcement on clinical trials that involve people instead of early medical device testing in labs.
"This decision ... may result in an irreversible cascade of adverse consequences to the protection of the public," the Society of Quality Assurance wrote in a recent letter to Congress.