According to regulation, a new device must demonstrate “substantial equivalence” to receive 510(k) clearance. To establish equivalence, the new device must have the same general intended use as a predicate device. Substantial equivalence determination is also predicated on the technological characteristics of the device. New devices are often designed with patentable differences in technology. These differences can give the edge over the competition, but they can pose challenges in demonstrating “substantial equivalence.” It is the technical differences that give FDA pause, as it must establish whether the new characteristics affect safety or effectiveness.
With the 510(k) process under fire by Congress and a new FDA Commissioner with a reputation as a public safety proponent, it is no surprise that safety has taken a front seat in the 510(k) review process.
Sponsors of 510(k)s have seen an increase in requests for additional information from the agency this year, especially where the device has incorporated a new technology. In the past nine months, scrutiny of test data appears heightened as requests for test protocols, reports, and even raw test data are becoming frequent. Rationales for the statistical significance of sampling plans and justifications for the clinical relevance of the test environment also are becoming commonplace. For well-prepared companies, requests for photos of the test setup and lot numbers of the test units are minor inconveniences. However, if FDA suggests the technology differences require animal or human clinical data, the impact to the business plan can be detrimental. This is especially true for start-up companies with limited resources and under strict time constraints to satisfy investors.
The pre-IDE process is a tool providing industry with early feedback from the agency for devices incorporating new technology. It also helps avoid surprise requirements during the 510(k) review. While pre-IDE meetings are technically informal, as a general rule, sponsors of 510(k)s can have faith in implementing the feedback they have received. This is an opportunity to gather FDA’s initial perspective on a company’s device strategy, but it is not for the ill prepared. This is not a social visit. Pre-IDE submitters should come ready with their plan of action for testing the device, and be prepared to discuss the risks associated with the new technology. More importantly, they should delineate how the plan is designed to mitigate those risks. This early communication with the agency can help companies navigate the currently murky waters of appropriately demonstrating safety for their new device.
Until FDA issues more specific guidance, 510(k) sponsors should ensure that technological differences between the new device and the predicates are discussed in adequate detail. Risks associated with the new technology should be discussed in conjunction with the mitigation efforts taken. For technology changes with higher risks, a pre-IDE meeting may be the most prudent, and ultimately cost-effective, course of action.
Rebecca Pine is senior consultant with Noblitt & Rueland. She has more than 18 years of experience in medical device research, development, and regulatory compliance, both at leading industry corporations as well as small start-up businesses. She has authored numerous successful 510(k)s, original PMAs, PMA supplements, technical files, and design dossiers. Her background includes all aspects of domestic and international medical device regulatory/quality management for a variety of products including orthopedic, pain management, cardiovascular, and electromedical devices; animal tissue products; nuclear medicine; and in vitro diagnostics. Pine holds a Bachelor of Science degree from the University of New York (Regents College) and is a member of the Regulatory Affairs Professionals Society. For more information about Noblitt & Rueland, which provides consulting and training services for medical device and IVD manufacturers, view its listing in the Consultants Directory or go to the company’s Web site at www.fdaconsulting.com.