(Adds analyst comments)
By Esha Dey and Susan Kelly
April 22 The U.S. Food and Drug Administration
on Tuesday proposed speeding up medical device approvals for
patients who have no other treatment options through a new
program focused on earlier and more frequent interactions
between companies and FDA staff.
The Expedited Access Premarket Approval Application program
is a response to criticisms by policymakers, patient groups and
industry that the FDA process for approving medical devices is
inefficient and slow, delaying patients' access to new, helpful
The program is not a new pathway to market, the agency said,
but rather a change in approach aimed at reducing the time it
takes to develop a product and get it to market.
It is similar to a new FDA program intended to expedite
development of certain cancer drugs in the clinical trial stage,
Morningstar analyst Debbie Wang said.
"This is yet another aspect of how FDA is trying to work in
a more coordinated fashion so they can reduce the number of
false starts and situations of reinventing the wheel, and to
help put some priority on which therapies are going to affect
the most patients with the greatest need," Wang said.
A device can be eligible for the program if it features
breakthrough technology with significant benefits over existing
In recent years, review times dragged out as the FDA faced a
rising number of new product applications. Recent increases in
the user fees paid by industry to fund FDA work could be
providing more wiggle room for the agency to devote manpower to
improving the application process, Wang said.
The FDA issued a rule in September that requires device
manufacturers to put unique codes on their products to enable
regulators to track and monitor them in the event of a safety
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, which 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The FDA also published on Tuesday draft guidance on when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
post-market data collection are not met. The regulator is now
seeking public comment on the proposals.
(Reporting by Esha Dey in Bangalore and Susan Kelly in Chicago;
Editing by Maju Samuel and Paul Simao)