FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA.
Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health says, “Today’s guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protections, and they propose efficient ways to support product or study design changes once the study begins.” This sounds like good news to industry; however, the guidance document is severely limited in two respects; first, the guidance is draft guidance that explicitly requests industry comments within 90 days (February 11, 2012) and second, the draft guidance is only open to nine sponsor devices for 180 days due to FDA resource limitations. Apparently, FDA’s reasoning is that data from the pilot program will help improve the final guidance.
FDA’s ability to give clear or unambiguous guidance is understandable for numerous reasons; most notably the wide array of technologies and health issues that may be addressed in a single guidance document. But, when FDA is afraid to take a position and back the position with reasoned certainty, it is if not harmful to potential patients, it is expensive and a waste of resources for industry to wade through the double speak. For example, the draft guidance states at Section 5.2.2 “Though not required for IDE approval, it may be valuable to submit a pre-IDE to obtain FDA feedback on the overall device development plan by identifying the types of information or levels of testing that may be needed to progress beyond the early feasibility study.” However, the draft guidance at Section 2.0 states, “Pre-submission discussions with FDA are necessary to optimize the preparation and quality of early feasibility study IDE applications.” (emphasis added)
FDA and industry have published data on the average time for IDE approval. Industry places the average time from initial contact with FDA to IDE approval at 14 months while FDA continues to state that the average time is six months. (CDG Whitepapers) While FDA states that IDE applications are granted on average 27 days, this ignores economic realities. It is difficult for industry to reconcile how FDA can operate a small pilot program for 180 days and obtain meaningful information to publish final guidance. FDA did not publicize how many resources or man-hours went into drafting this innovative draft guidance. It will be interesting to see how many sponsors file IDE’s or request pre-IDE meetings with FDA for this pilot program.
This guidance is just another example of FDA playing politics and ignoring the economic realities faced by innovative US companies. It sounds good and it may be a step in the right direction, but come on FDA, let’s try to be clear about what industry can expect.
Eric B. Alspaugh, Esq. is a registered patent attorney specializing in the prosecution and litigation of utility and design patent applications, and obtaining protection for all intellectual property. Eric is a member of the Orange County California Bar Association and is licensed to practice in state and federal court. For more info: Visit www.alspaughlaw.com or email firstname.lastname@example.org