Originally Published MDDI January
2005
Regulatory Outlook
FDA’s Third-Party Programs
Harvey Rudolph and John Stigi
Underwriters Laboratories Inc. and CDRH
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The first pilot program included all Class I devices and selected Class II
devices. Class II devices were allowed if the number of submissions per year
was significant and if FDA guidance existed for the review. In 1997, this pilot
program was written into law through the FDA Modernization Act (FDAMA). FDA
accredited 14 third parties to review 510(k)s under the new Accredited Persons
510(k) Review (APR) program. Under the program, manufacturers could choose to
pay a third party to review their submission. Manufacturers could still opt
to have FDA do the review at no cost. One might wonder why manufacturers would
willingly pay for something that was available at no charge, but the theory
was that the free market would introduce efficiencies that would make the reviews
occur more quickly. The law required FDA to make a determination on a third
party’s recommendation within 30 days to create a faster road to clearance
that might be more attractive to manufacturers.
FDAMA’s legislative history makes it clear that Congress expected FDA to
expand the scope of devices eligible for third-party review. FDAMA excluded
only Class III devices and the following Class II devices: permanently implantable,
life sustaining or life supporting, and those that require clinical data in
a 510(k).
FDA ultimately expanded the list of eligible devices to the full scope permitted
by FDAMA, first by adding all allowable Class II devices for which FDA review
guidance existed. In 2001, FDA added devices that do not have FDA review guidance.
The sunset date for the APR program was extended to October 1, 2007, with the
passage of the Medical Device User Fee and Modernization Act (MDUFMA) in 2002.
More importantly, MDUFMA also established FDA user fees for 510(k)s that are
submitted to FDA with no third-party review.
MDUFMA also introduced another third-party program, the Accredited Persons Inspection
(API) program. Industry lobbied for the API program. Many manufacturers experience
multiple visits from various regulatory authorities or conformity assessment
bodies to inspect or audit their quality management systems. Ideally, combining
these audits into a single regulatory audit would save the manufacturers and
the regulatory bodies both time and money.
As an initial step in that direction, FDA has accredited and trained the first
14 accredited persons to perform regulatory device inspections. The agency is
in the process of qualifying, via joint audits, these third parties. As in the
APR program, manufacturers can choose to pay an accredited person to perform
the inspection or wait for an FDA inspection.
FDA also administers another third-party program related to inspections and
510(k) reviews. This program is derived from the mutual recognition agreement
(MRA) signed by the United States and the European Union (EU) in 1998. Under
the MRA, the EU designates EU conformity assessment bodies (CABs) to perform
FDA inspections for device manufacturers based in Europe that are marketing
devices in the United States. The CABs are also trained and accredited to review
510(k)s for devices (which are listed in the MRA) that are produced in Europe
for marketing in the United States. On the U.S. side, FDA designates U.S. CABs
to audit firms that produce devices in the United States for marketing in Europe.
These CABs are accredited to perform Annex II (complete quality assurance system)
audits or Annex III (type examinations) audits that are acceptable to notified
bodies in Europe.
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