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 Commissioner Scott Gottlieb announced the proposal in a blog posted
on the FDA's website. If implemented, it could save device companies
millions of dollars in product testing and shave years off
development times.
The proposals make good on President Donald Trump's promise to cut
regulations and sparked concern from public health advocates who
fear the moves will harm patients. Already dozens of devices are
recalled each year.
Gottlieb's proposal would offer an alternative route to market for
certain companies who do not meet the criteria for clearance under
the agency's existing fast track route, known as the 510(k) pathway.
To win 510(k) clearance a product must be moderate risk and
substantially equivalent to an existing device, called a predicate.
High-risk products such as implantable heart devices must go through
a more rigorous process.
Gottlieb said that advancing technology means it can be hard for
companies to identify a suitable predicate, "which can create an
obstacle to certain kinds of innovation and lead to inefficiency in
the review process."
His new proposal would dispense with the need for a predicate and
offer the option of using a benchmark consisting of a set of
performance standards or guidance documents. The plan would be
voluntary.
Janet Trunzo, a spokeswoman for the industry organization AdvaMed,
said the organization "commends FDA's commitment to promoting
patient access to medical technologies through innovative regulatory
pathways."
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Gottlieb said the FDA will also examine ways to speed the path to
market for high risk products by re-evaluating the amount of safety
data needed prior to approval. The agency will issue guidance
shortly outlining "how certain issues could be ultimately resolved
in the post-market setting, rather than the pre-market setting, to
allow patients to gain faster access to potentially life-saving
devices."
Dr. Rita Redberg, a cardiologist at the University of California San
Francisco and editor of JAMA Internal Medicine, said shifting safety
monitoring from the pre-approval to the post-market setting would
turn patients into guinea pigs.
"When we use devices on patients without clinical studies first, the
patients effectively become the trial and the insurers become the
funder of the device trial," she said.
Others echoed Redberg's concern.
"I see a potentially huge problem in moving more risk to the
post-approval setting," said Areta Kupchyk, a partner at Foley Hoag
and former associate chief counsel at the FDA. "It's very difficult
once a product has been approved to pull it back."
(Reporting by Toni Clarke in Washington; Editing by Cynthia Osterman)
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