NEWS
04/03/1996
FDA ANNOUNCES REFORMS OF MEDICAL DEVICE PROCEDURES
P96-7 Food and Drug Administration
FOR IMMEDIATE RELEASE Sharon Snider (301) 443-3285
April 3, 1996
FDA'S ANNOUNCES REFORMS OF MEDICAL DEVICE PROCEDURES
The Food and Drug Administration today announced initiatives
that will streamline, simplify, and reduce the regulatory costs
of the medical device industry while maintaining important public
health and consumer safety protection.
"Under the leadership of President Clinton, the FDA is
adopting a common sense approach to regulating the medical device
industry," said Vice President Gore, whose National Performance
Review program includes regulatory reform as part of the effort
to make the federal government work better and cost less. "The
FDA is eliminating unnecessary and burdensome regulations while
still maintaining critical public health protection. The result
is safe, new medical devices that will be available to the Ameri-
can people in record time."
One initiative, will test whether allowing private organiza-
tions to participate in evaluating medical devices will reduce
review times and whether strong conflict-of-interest rules can be
maintained in such a process.
"This pilot program is another example of FDA's innovative
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regulatory strategy for the 21st Century," said HHS Secretary
Donna E. Shalala. "It explores how the agency can best review
relatively low-hazard products while enabling the agency to
target its resources where the risks are high."
"The test for any reform is whether it protects the public
health," said FDA Commissioner David A. Kessler, M.D. "Our
proposal will test whether this speeds up the process and if the
integrity of the review can be maintained."
The pilot third party review program will only apply to low
and moderate risk devices for which FDA does not require clinical
data on safety and effectiveness -- products such as electronic
thermometers and surgical gloves. Manufacturers are required to
show in premarket notification (510k) applications that products
in this category are comparable in safety and effectiveness to a
device already legally marketed. FDA receives about 1,500 appli-
cations of this type a year.
Participation in the pilot program is voluntary. Firms can
opt to have most of the review conducted by a third party, or
leave the entire procedure up to FDA.
If an outside review is chosen, the manufacturer selects an
FDA-recognized third party and submits to it the marketing
application. The organization reviews the product and submits
the application, the results of its review, and its recommenda-
tion to an FDA supervisor for a final assessment, thereby bypass-
ing the
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first phase of FDA's routine review process. An agency decision
will be made within 30 days.
FDA will closely monitor the pilot program and make any
necessary changes to protect the public health. The program is
expected to begin in mid-summer and run for two years. In the
near future, FDA will announce the date of an information meeting
for prospective third party reviewers to clarify the criteria for
their eligibility for participation in the program.
FDA's second initiative is the result of a series of "grass-
roots" meetings with medical device manufacturers conducted last
year by the agency as part of the National Performance Review.
The nation-wide exchanges, which were focused on FDA's inspec-
tions for compliance with federal standards, resulted in an
initiative jointly developed by FDA and a task force of industry
officials. The proposed changes of FDA inspection procedures
will apply to firms with a good history of past compliance with
FDA requirements.
These changes include:
o advance notification of inspection instead of the routinely
conducted unannounced inspections. The prior announcement will
enable the firm to prepare for the inspector's visit and be
better ready to answer questions;
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o an opportunity for firms to note on the official inspection
record violative findings that had been immediately corrected.
In the past, FDA records listed only the findings, regardless
whether or not they had been corrected immediately; and
o a letter from FDA informing firms found in compliance that
they had successfully passed the inspection, a recognition that
was not accorded in the past.
The program will begin immediately as a pilot project. If
successful, it will be expanded to other manufacturers of FDA-
regulated products.
The third initiative affecting mainly the food and drug
industries, but also applicable to the medical device industry,
is a proposal that would streamline and simplify FDA's procedures
for complying with the requirements of the National Environmental
Policy Act. The proposal, which the agency will soon publish,
covers all FDA-regulated product areas and greatly reduces the
number of environmental assessments the industries have to
prepare for FDA's review.
The agency has found that many of the actions for which it
presently requires environmental assessments have no significant
effect on the environment, and their elimination will enable FDA
to focus greater resources on those areas that present real
potential for environmental impact. The agency believes that
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these reforms will result in no additional risks to the environ-
ment, while saving the industry annually as much as an estimated
$15 million, and the agency as much as $1 million.
The announced initiatives are part of a series of over 40
individual reforms that been identified by the FDA and the
National Performance Review. The two medical device programs
will begin immediately. The proposed elimination of most envi-
ronmental assessments will be submitted to public comment, with
final regulations expected later this year. Meanwhile, some
manufacturers are already beginning to submit abbreviated assess-
ments under informal guidance issued by FDA.
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