By Carmelina G. Allis –
A March 24, 2011 warning letter from FDA cites a rarely invoked provision in the Investigational Device Exemption (“IDE”) regulations. It is not clear whether this warning letter is an outlier or a harbinger of more aggressive inspections by the Division of Bioresearch Monitoring (“BIMO”).
The recipient of the letter was Valor Medical, Inc. FDA alleged that the company violated 21 C.F.R. § 812.27(a) (and Section 520(g) of the Federal Food, Drug, and Cosmetic Act) by failing to submit two animal study reports in its IDE application. That is the only violation listed in the letter.
Pursuant to 21 C.F.R. § 812.27(a), an IDE sponsor must submit “reports of all prior clinical, animal, and laboratory testing of the device . . . to justify the proposed investigation.” Generally, sponsors submit reports of those tests that are relevant to the proposed investigation – they don’t just simply submit all of the tests conducted on the device. For example, if an animal study was conducted on a prototype device that differs significantly in technology or design to the proposed device, the sponsor may not submit that information in the IDE. The same would apply if the study was conducted, for example, using an animal model that proved to be inadequate to assess the device performance or its safety or effectiveness (necessitating a second study in a different animal model). In both of those cases, the test results would not provide any valuable safety or effectiveness data regarding the proposed device, and the information would not be relevant to justifying the proposed investigation.
It is rare for a warning letter to cite § 812.27: the only other one we can find is a warning letter issued to Staar Surgical in 2007. That letter cited the company for withholding information regarding a human clinical study that the company had conducted prior to submission of the IDE.
FDA failed to describe in the Valor Medical warning letter the importance or relevance of the animal studies for purposes of the IDE study. This is unfortunate because there is no way to judge whether the omitted animal studies were clearly relevant, or whether FDA has expanded its interpretation of what studies must be submitted.
As noted, we are not sure if this warning letter is an outlier or a harbinger. It does underscore that companies should carefully consider what studies are properly included in an IDE application.