Case Study
Maintaining FDA approval: Substitute material
FDA approval is required for everything from bedpans to
pacemakers. And although a splintered tongue depressor is generally
not life threatening, deterioration of the surface coating of a
stent can present a more serious problem. Regardless of the
application, the materials used in the production process of a
medical device are critical to the product's performance and
require FDA approval.
Our client successfully navigated the strenuous FDA-approval
process to bring its medical device to market, but subsequently
discovered its material supplier would no longer be able to provide
the same material. Not having an alternative source for this
material, our client had to demonstrate, according to FDA
regulations, that a change in the source material for the device
would have no effect on patient safety or product performance. They
needed scientific justification as a confirmation that the previous
testing results would still apply. Without this justification, the
client would have to re-test and re-submit results for FDA
approval, incurring additional costs and consuming valuable time.
RJ Lee Group collaborated with our client in the analysis of the
replacement material and helped demonstrate that the properties and
characteristics of the new material were not substantively
different than the originally tested and FDA-approved material. Our
technical approach and materials expertise provided a sufficient
scientific basis to attain ongoing FDA approval without the need
for re-testing. This helped our client maintain market position and
saved the costs associated extensive re-testing and re-submission
to the FDA.
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