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.