Posted:
February 13, 2014 - 3:30 pm ET
Hospitals,
physicians and their patients soon may know if a medical device is faulty more
quickly than in the past thanks to a Food and Drug Administration final rule
issued Thursday. The rule requires
manufacturers to submit reports of injuries or deaths associated with their
products electronically to the FDA instead of via a paper report as is
currently done.
Electronic
submissions will make it easier for the FDA to review adverse events and rapidly communicate
information about suspected problems to the medical-device industry, healthcare
providers, consumers and other government agencies, it said in the rule.
For
decades, the FDA has received these reports in a paper format through the mail.
In 2009, the agency released a proposed rule that called for electronic reports
on a voluntary basis. The
final rule makes it mandatory to do so starting Aug. 14, 2015.
The
FDA on average receives
roughly 200,000 adverse events annually and can take anywhere from three
days to six to properly analyze a report received by mail, according to the FDA. Others argue it
could be even longer in some instances.
“It is no secret that, for
years, paper
medical-device reports were mostly warehoused,” said Jeffrey Shapiro, an
attorney at Hyman, Phelps & McNamara.
The
FDA estimates it oversees more than 20,000 device manufacturers and importers.
The industry will face one-time
costs of $40 million in training and IT changes to make the switch, the
FDA estimated. However,
device makers will save about $9.2 million annually because electronic
submission should reduce the time needed to submit documents and reduce
delivery costs.
A
major change between the proposed and final rule: user facilities such as hospitals will not be required to
comply with the e-filing requirement.
“This
change from the proposed rule was obviously in response to comments concerning
the increased costs for electronic submissions by entities that file a small
number of reports each year,” said William Kitchens, a partner at the law firm
Arnall Golden Gregory.
Small
devicemakers are not exempt from the new requirement, however.
“There
are many very small device manufacturers and I believe that this is going to be
a burden for them,” said Wally Pellerite, an industry consultant and former FDA
compliance official, adding that it makes the agency appear inconsistent to
exempt hospitals but not small devicemakers. “Small device firms with few
medical-device reports should be allowed to submit paper reports.”
Follow
Virgil Dickson on Twitter: @MHvdickson
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