FDA 510(k) Announcement

February 3, 2011 – Blog Post

The FDA announced, in a January 19, 2011 press release, its plans to improve procedures regarding medical devices under 21 USC § 360(k) (better known as Food, Drug, and Cosmetic Act § 510(k)) this year. This statute requires submission of medical device information to the FDA prior to introducing a medical device on the market where the medical device is a modification of another previously-available medical device.

In the press release and in an open letter, the FDA identified its aims to bring about “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.” The FDA notes that it has heard concerns about unpredictability of its procedures that may hurt investment in innovation, about the level of sufficiency and openness of its reviews of device safety, and about inadequacy of its procedures to address the increasingly complex devices it reviews. To address these problems, the FDA established internal groups to examine the concerns in September 2009. These groups issued preliminary internal evaluations in August 2010, and the recent FDA press release announced plans to implement some of these recommendations.

The FDA categorized its list of 25 planned “Action Items” into three categories: guidance, internal and administrative matters, and programmatic and regulatory matters. Regarding guidance, the FDA’s plans include streamlining the de novo classification process for automatic Class III designation as well as clarifying requirements for when new devices warrant a new 510(k), processes for appealing adverse 510(k) decisions, and 510(k) submission information requirements and criteria. The FDA’s internal and administrative 510(k) plans include establishing a Center Science Council to help 510(k) review reflect new scientific developments, enhanced procedures for hiring and training staff, and otherwise employing technical knowledge and expertise in its decisions. Programmatic and regulatory plans include several information-related improvements involving releasing non-proprietary device photographs, using data in quantitative decision making, alerting stakeholders about changed expectations, identifying devices, documenting transfers of ownership, and developing an online labeling repository.

The FDA’s planned “Action Items” list also sets forth seven weightier issues to be referred to the Institute of Medicine. These include authority to rescind 510(k) clearance, authority to require postmarket surveillance, development of a “Class IIb” for medical devices, consolidation of “indication for use” and “intended use” concepts, and possible pursuit of a statutory amendment.

While the FDA states a willingness to support innovation, it provides little detail on its plans’ inclinations for or against the medical device industry, particularly where the plans involve “clarification.” However, these plans to clarify 510(k) procedures at least appear as though they will provide those in the medical device industry with more certainty as to FDA dispositions regarding their products. Certainty in government regulatory schemes can stimulate investment in industry.