[author: Michael A. Swit]
mHealth Newsletter - November 14, 2012
In a recent move that mobile medical application developers may want to emulate, AliveCor—the developer of a mobile electrocardiogram (ECG) system awaiting U.S. Food and Drug Administration (FDA) blessing for human use—has introduced what appears to be essentially the identical product for the veterinary market, and without getting FDA's permission.
AliveCor's strategy takes advantage of what might be considered a gap in FDA's regulatory regime. Specifically, medical devices labeled solely for veterinary use do not require any type of prior clearance or approval by the FDA. While such devices still must be properly labeled and also manufactured under appropriate quality conditions, the agency lacks specific statutory authority to require submission of anything resembling a pre-market notification submission [510(k)] or Premarket Approval Application (PMA) as might be required for an identical device intended for human use.
mHealth medical device innovators interested in pursuing this veterinary approach should keep in mind that the absence of a need for FDA approval or clearance does not eliminate the need to have adequate substantiation for any claims made about a product's effectiveness or safety in the species targeted for the product. Inherent in FDA's statutory authority to prevent the marketing of adulterated or misbranded devices is the power to probe the adequacy of the substantiation of labeling claims. In addition, depending on how the product is marketed, concurrent jurisdiction may exist between FDA and the Federal Trade Commission (FTC). The FTC also expects marketers to have appropriate substantiation for product claims.
AliveCor's strategy of pursuing a veterinary medicine use, even pending FDA clearance of its human model, is a creative development in the mHealth arena. However, while FDA preclearance is not required, care should be exercised in pursuing an animal health use for a mHealth product, including not only ensuring adequate substantiation of label claims, but also conforming to FDA's general regulations applicable to veterinary medicine devices. Regardless of whether it is subject to FDA preclearance, developers should incorporate appropriate risk-management steps to maximize the safety and efficacy of any product that impacts human or animal health.
Michael A. Swit's practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products.