Physicians Office Resource Volume 8 Issue 04 | Page 23

F

PHYSICIANS OFFICE NEWS BRIEFS
DA Proposes Accelerated
Medical Device Approval Plan

separate draft guidance outlining the agency's
current policy on the timeline for data to be
collected after product approval and what
actions are available to the agency if approval
conditions, such as postmarket data collection,
are not met. Advice on the use of surrogate or
independent markers to support approval, similar
to those seen for accelerated approval of
prescription drugs, is included in the guidance.
"We are excited to offer a proposed
program for expedited access for certain highrisk medical devices," Jeffrey Shuren, M.D.,
director of the FDA's Center for Devices and
Radiological Health, said in a statement. "The
program allows manufacturers to engage
early and often with the agency. We expect
most devices that enter this program will be
in the pre-clinical trial phase."

The U.S. Food and Drug Administration
has proposed a new program that
would provide expedited access to
high-risk medical devices intended for patients
with serious conditions whose medical needs are
not met by current technology.
The proposed Expedited Access Premarket
Approval Application for Unmet Medical Needs
for Life Threatening or Irreversibly Debilitating
Diseases or Conditions ("Expedited Access PMA"
or "EAP") program features earlier and more
interactive engagement with staff from the FDA.
This will include the involvement of senior
management and a collaboratively developed
plan for collecting the data to support approval.
According to the FDA, EAP is not a new
pathway to market, but rather an approach where
all parties work together to facilitate product
development under the agency's existing
regulatory authorities. EAP seeks to reduce the
time associated with product development, not
just reduce the time for the premarket review. In
addition to the program, the FDA has published a

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