Methods in validating tests
YOUR RISK, YOUR RESPONSIBILITYIt may seem contradictory, but FDA regulations do give medical device packagers some freedom.
“The beauty of FDA [regulation] is that it is up to you to pick a position and justify it,” says Laura Bix, Ph D, assistant professor, Michigan State University School of Packaging.
If you cannot defend your position, it could mean that you are not correct.”Companies, though, may look for a less risky course of action.
Adds Troedel: “The compendium, as currently planned, will include medical device test methods from multiple sources. VALIDATEAs “off-the-shelf” as the methods in Annex B of ISO 11607 seem to be, though, if a medical device manufacturer has chosen to use a listed method, there is still work to do.But just because a method is listed in the annex or recognized by FDA does not mean that it will work for every medical device manufacturer and for every medical device package.Determining the appropriateness of a particular method—and validating that method for a given package and in a given lab—is the responsibility of each medical device manufacturer.“But you’ve got to be able to defend that position.There is a degree of uncertainty, so the choices you make depend upon the risks you want to assume.
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While not a new concept, test method validation continues to challenge packaging professionals throughout the industry.