The FDA Selects Apple and 9 other Tech Companies for Pilot Program Designed to Fast Track Mobile Device Innovations
A new report today reveals that the Food and Drug Administration, which oversees new drugs, medical devices and much of the U.S. food supply, said Tuesday that it had selected nine major tech companies for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products. The program is meant to let the companies get products pre-cleared rather than going through the agency's standard application and approval process that can take months. Along with Apple, FitBit Inc., Samsung Electronics Co., Verily Life Sciences, Johnson & Johnson and Roche Holding AG will participate.
Bloomberg notes that "Apple is studying whether its watch can detect heart abnormalities. The process it will go through to make sure it's using sound quality metrics and other measures won't be as costly and time-consuming as when the government clears a new pacemaker, for example.
Verily, the life sciences arm of Google parent Alphabet Inc., is working with Novartis AG to develop a contact lens that could continuously monitor the body's blood sugar.
FDA Commissioner Scott Gottlieb said in a statement that 'We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate.'
The FDA program is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that may be used by patients or their doctors to prevent, diagnose and treat conditions.
"Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life," Gottlieb said in July when he announced that digital health manufacturers could apply for the pilot program." For more, read the full Bloomberg report here.
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