(Adds details, background)
April 22 The U.S. Food and Drug Administration
proposed on Tuesday a more collaborative approach aimed at
speeding up marketing approval for high-risk medical devices
intended to treat patients with serious conditions that have no
other treatment options.
The proposed Expedited Access Premarket Approval Application
program would feature earlier and more frequent interactions
between companies and FDA staff. (r.reuters.com/kaw68v)
The proposal is a response to criticisms by policymakers,
patient groups and the industry that the FDA's process for
approving medical devices is inefficient and slow, thereby
denying patients access to new, helpful products.
The program is not a new pathway to market, the FDA said,
but rather a change in approach aimed at reducing the time it
takes to develop a product and get it to market.
A device can be eligible for the program if it features
breakthrough technology with significant benefits over existing
The FDA issued a rule in September that requires device
manufacturers to put unique codes on their products that will
allow regulators to track and monitor them in the event of a
Also in September, the agency issued final rules on mobile
medical apps, saying it would only regulate apps that transform
smartphones into devices that the agency currently regulates,
such as electrocardiography machines that can determine whether
a patient is having a heart attack.
The FDA also published on Tuesday draft guidance on when
data can be collected after a product's approval and what
actions the agency can take if approval conditions such as
postmarket data collection are not met. The regulator is now
seeking public comment on the proposals.
(Reporting by Esha Dey in Bangalore; Editing by Maju Samuel)