Biomedical Engineering Reference
In-Depth Information
28 May 1976 or to a device that has already gone through the 510(k) clearance process.
Devices that have already successfully gone through the 510(k) process are described as
'510(k) cleared,' whereas PMA devices are 'approved.'
Under section 510(k), a previously cleared device included for comparison purposes is
called a predicate device and may contain multiple predicate devices that address various
features of the device. The device designers should provide regulatory personnel with
assistance by identifying key technological characteristics that demonstrate substantial
equivalence. These data should already be part of the design inputs required as part of
design controls, although, generally, little manufacturing data are included in 510(k). Ster-
ile devices include information on the sterilization process, including validation activities
and the sterilization assurance level.
In vitro
diagnostic products will frequently include
data on the production of key reagents such as antibodies or nucleic acid probes. The
other part of substantial equivalence relates to the indication for use since, frequently,
one medical device can be used for many indications in a variety of medical specialties.
When new indications are added, these must be cleared in a traditional or abbreviated
510(k) in which a predicate device with the same indication for use must be cited.
When searching for potential predicate devices, several information sources are useful.
Two FDA databases, the 510(k) database [11], and the classification database [13] can be
very helpful. The 510(k) database is especially useful when one knows either the name of
potential predicate devices or the manufacturer of the device. The classification database
can be used to identify a particular device type and its corresponding product code. One
can then transfer the product code to the 510(k) database and generate a listing of all
similar devices. Sales and marketing staff, together with competitor web sites, are also
excellent sources of predicate device information [10].
As a periodical assessment of the effectiveness of existing programs, the FDA launched
a comprehensive assessment of the 510(k) process in 2009. The combined result of the
FDA internal assessment and an evaluation done by the Institute of Medicine (IOM) was
a report with 55 recommendations to improve the process. Currently the FDA intends to
initiate 25 new actions to implement 47 of the 55 recommendations, including develop-
ment of new guidance on staff training. The new 510(k) action plan will be implemented
to improve product safety.
12.3.3 The Premarket Approval Application
PMAs are necessary when the device the developer wishes to market is innovative in the
United States and is not substantially equivalent to any other device that has been cleared
through the 510(k) process. By necessity, the PMA process is much more stringent than
the 510(k) process since it must demonstrate that the device is safe as well as effective,
and typical review times are approximately one year. Unlike most 510(k) processes, a
detailed manufacturing section describing the methods for building and testing the device
must be included. Prior to final approval of the PMA, the CDRH office of compliance must
review and approve the results of a preapproval inspection of the device manufacturing
and development facilities. The sponsor of the clinical trial, and two or three of the
clinical investigation sites, are also often subject to CDRH bioresearch monitoring (BIMO)
inspections to confirm compliance with relevant sections of 21 CFR 812. Finally, the
postmarket requirements of a PMA are considerably more complex than those related to
