by Anna Longwell, Esq.

Device Clinical Trials

C. I.D.E, 21 CFR 812

This rule allows shipment of devices (there is no legal definition of a “new” device) without requirements for registration, listing, device labeling, and device GMP, 510(k) or PMA, by imposing another set of requirements instead.

There are two types of IDE, for significant risk devices (full IDE) and for non-significant risk devices (abbreviated IDE). The full IDE requires a submission to FDA and approval by FDA. The abbreviated IDE is “considered approved” as long as the requirements of the regulation are met. Contrast this to the IND, which is not “approved”, is simply “in effect”, always requires a submission, and requires that the new drug be manufactured under drug GMP, with the exception of expiration dating.

What are the IDE requirements? First, the sponsor has to decide what proposed intended use of the device would be studied. If the intended use is as an implant or is some other use that presents a serious risk to the health and safety of the subject, then the sponsor must use the full IDE route. If not, the sponsor must present his conclusion that the device to be studied is not significant risk to the reviewing IRB. If the IRB concurs, no submission to FDA will be necessary.

What does remain necessary are the responsibilities of sponsors (fairly similar to IND responsibilities of sponsors), responsibilities of investigators, requirements for IRB initial and continuing review, a prohibition on promotion, special investigational labeling, and clinical inventory control. What is different from the IND is the requirement for design control and a provision allowing sale of the device without additional FDA permission, as long as the price is not greater than a “cost recovery” price.

D. Design Control, 21 CFR 820.30

This is a relatively new segment of the device GMPs, now called the “Quality System Regulations” (QSRs), since the extensive revisions in the mid 90s. Design controls consist of a set of documented and controlled procedures for design planning, design input, design output, design validation, design verification, design review, design transfer and design changes. Design verification is proof that the product meets its design specs (design output). Design validation is proof that the design actually functions as expected (design specs make sense in terms of product use).

The regulations require that a design history file be kept. The file will contain the development plan and any revisions, design input documents plus any changes to design input, design output plus any changes to design output, periodic risk analyses, minutes of design reviews, results of validation and verification testing. Documents requiring approval signatures are design plan, input and output, plus any changes to these. Documents requiring signature of persons performing tests are results of verification and validation testing. Additionally, It’s a good idea to have attendees sign the design review minutes, especially for design reviews that are prior to use of the product in humans, and have the purpose of determining the devices’ readiness for investigational use.