Answering the Device Industry’s Call for Clarity

By: Jeffrey Shuren, M.D., J.D.

Have you ever had to puzzle through opaque instructions for operating some electronic gizmo? It can be a frustrating, time-consuming process.

Sometimes that’s how the medical device industry views FDA. They clamor for greater
clarity on a variety of agency programs, as we began to learn in 2009 when the FDA’s
Center for Devices and Radiological Health started taking a look at our pre-market

Dr. Shuren Photo

We reached out to industry during that process and they told us one of their primary concerns was a lack of clear guidance. They said their companies depend on a clear regulatory pathway to avoid unnecessary costs and bring new, safe and effective devices
to market in a timely manner. We listened, and in January, when we announced our plan to improve our pre-market programs, issuing clear guidance was an integral part of our plan.

Since then, we’ve issued several clarifying guidance documents including one on clinical trials and another on the evaluation of “de novo” devices – novel lower-risk devices. Now, as the year comes to a close, we’re out with three additional draft guidances. One outlines the process for appealing CDRH decisions. The second explains how product codes should be developed and used. And the third helps clarify how FDA decides whether a device is “substantially equivalent” to a legally-marketed device under the 510(k) program. Every year some 4,000 lower-risk devices are cleared for marketing using this streamlined process, the most common pathway to market for medical devices. This latter guidance on substantial equivalence addresses what information should be in a submission, explains how the FDA decides whether clinical data should be required, and provides a decision-making flow chart to help manufacturers through the application process, an approach we know is popular with industry. Importantly, it does not alter our review standards, the 510(k) review processes, or the agency’s data requirements. Instead, it makes the existing regulatory framework more transparent and predictable by clearly articulating many of the longstanding practices and policies underlying the 510(k) program.

At 116 pages, the substantial equivalence guidance is admittedly long, so we’ll be
offering a free online training program to walk industry through the document’s various
segments. And, like all of the other guidance we’ve issued this year, it is just draft. That
means it’s not written in stone; we’re actively soliciting feedback from industry and other
interested stakeholders.

As I look back over 2011, I can report that we have made significant progress on the
actions we committed to take this year to improve our pre-market programs. To see for
yourself, just follow this link to a table that charts our accomplishments.
Once these policies and processes are finalized and implemented, we expect to see a significant and positive impact on the pathways to market for medical devices.

Jeff Shuren is the Director of FDA’s Center for Devices and Radiological Health

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