5 Ways to Avoid
Critical Testing Errors
for Regulatory Submissions
By Martell Winters, RM/SM(NRCM),
Senior Scientist and Consulting Manger, and
Scott Dimond, SM(NRCM), Section Leader,
Many obstacles can be encoun- tered along the road to a suc- cessful regulatory submission.
To ensure greater probabilities of success,
it is important that medical device OEMs
familiarize themselves with the proverbial
roads, traveling conditions, warning signs,
and hazards they may encounter. Many
of the most critical laboratory testing
and regulatory submission errors can be
avoided by asking two questions:
1. Has my test plan been properly structured (or, are we performing the right
combination of tests)?
2. Are the scientific rationales behind my
test plan being properly documented
It is also critical to remember that
roadside assistance is available in the form
of qualified laboratory partners and expert
testing consultants that should be involved
early in the device development process
and throughout the complete lifecycle of
the product. Doing so will help avoid unnecessary testing, expedition fees, re-test-ing, and regulatory delays; and protect the
long-term efficacy of the device.
1. Find a Quality Testing Partner
In selecting a testing partner, seek an
organization that is focused on educat-
ing its client. While a company may not
be looking to become a testing expert,
understanding the “what” and especially
the “why” of the testing being performed
is important. The testing landscape is
constantly evolving, and a good labora-
tory or consultant will be well informed
of changes coming from notified bodies,
have inside information on regulatory
behavior and standards interpretation,
and be able to steer a medtech company
in the right direction.
2. Invest in Testing Consultants
Manufacturers are quick to invest in regulatory support, but unfortunately, do not
often bring in a testing specialist to coordinate and oversee the testing and submission processes. Few companies have a microbiologist on staff, let alone an in-house
testing expert. Often, the function of
coordinating microbiology and sterilization testing and submissions is placed on
non-microbiologists or non-sterilization
personnel. Although well-versed in their
areas of expertise, microbiology and sterilization are not often included as being
areas of deep knowledge.
Since you don’t know what you
don’t know, medical device manufacturers should consider enlisting a testing
consultant, in addition to working with a
testing laboratory and regulatory support
professionals, to ensure an appropriate
test plan is executed and justified.
A simple but common issue in
medical device testing and regulatory
submissions is the selection of test specifications or acceptance criteria without a
documented explanation or justification
describing why those tests were selected.
For example, an extraction parameter
of 50°C for 24 hours might be selected,
when other temperatures and times are
also commonly used. Although seeming-
ly unimportant at the time, if questioned
by regulatory authorities, it will be criti-
cal to understand the scientific rationale
behind those decisions. Taking the time
to formally document the rationales will
greatly benefit the future personnel who
have to review the information. The
involvement of a qualified testing consul-
tant will help ensure this happens.
Testing consultants are distinct from
regulatory consultants in that they specialize in creating an appropriate test plan for
the product, oversee the testing process,
and document justification for the testing
plan to ensure both regulators and device
personnel have the information necessary
to defend the integrity of the test data.
3. Know What Testing to Request
Standards and guidance documents
are usually written in a broad manner.
This broad perspective is necessary for
these documents, which are meant to
be relevant to a wide variety of circumstances. However, they do not provide
the specific information necessary for a
particular healthcare product or situation;
this is something an expert in industrial
microbiology or sterilization can provide.
There are almost always subtle aspects of
a device that require unique approaches.
An expert will be able to pick up on those
nuances and adjust the testing approach
to be more appropriate. When medical
device teams do not have a laboratory
testing expert to consult with, they are
left to grapple with a loosely defined road
map to determine their testing needs.
There is also the issue of “industry
practice,” or the “unwritten industry
rules,” which can influence test plan decisions significantly. These sometimes fall
under the “c” of the FDA “cGMP,” which
stands for current good manufacturing
practices. These situations can be partic-