is less obvious. To better understand the issue, it’s important to
consider the concept of intrinsic safety.
Intrinsic safety can be thought of as the safety of the device
itself, in its final form. A device that intrinsically is very safe to use
in humans (for instance, a plastic adhesive bandage) can be un-
safe for use if it is not sterile when applied to a wound. An intrin-
sically unsafe device, for example, might be made of a material
with a high toxicity. No amount of sterilization will render that
device safe to use in humans. With this understanding, we will
next look at three classes of studies, and discuss whether GLP
should apply to those studies.
Biocompatibility studies are done to determine safety—looking
at the medical device’s effect on a biological
system to better evaluate potential safety in
humans. Therefore, FDA requires that biocompatibility for PMA submissions be done
according to GLP and has strongly recommended that biocompatibility studies in support of 510(k) submissions also be conducted
according to GLP.
Do validation studies need to be conducted
according to GLP? For instance, does a sterilization validation require GLP treatment? The
study is trying to validate the process that will
render the device free of microorganisms (and
thus safe for use in humans). However, the
study does not determine the intrinsic safety
of the device, and by that measure is not a
nonclinical safety study requiring GLP.
Yet there remains some debate as to whether validation studies need to be conducted according to GLP. Suffice to say that with more
than 30 years of experience, article authors and
the team at Pacific BioLabs has never seen GLP
as necessary for a validation study.
Rather than applying GLP standards, it is
more important that the study be conducted at
a facility with an adequate quality unit (
including the performance of an independent quality
control review of the study results). The extra
steps required by GLP are unnecessary, and
can add to both cost and duration of a study.
Chemical Characterization Studies
The GLP regulations do mention other stud-
ies not classified as nonclinical laboratory
studies and therefore not subject to GLP reg-
ulations. These include exploratory studies,
and studies done to determine the physical
or chemical properties of a device.
According to the regulations: “…basic
exploratory studies carried out to determine
whether a device has any potential utility, or
to determine physical or chemical character-
istics of a device, are not subject to the GLP
regulations ( 21 CFR 58.3(d)).” 4
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