The FDA’s New Proposed Regulations Affecting the Medical Device Approval Process

On August 4, 2010, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“FDA”) released a preliminary report which proposes several changes to the medical device approval process nationwide.

According to the FDA, the recommendations in the newly-released report are intended to enhance the predictability of the approval process for new medical devices while at the same time improving patient safety and expanding medical device innovation. It is the FDA’s position that adopting these new regulations will increase the predictability of the regulatory pathways, and thus stimulate new medical technology while increasing the global market position of medical devices from the United States. In a press release on this issue, the newly appointed Director for the Center for Devices and Radiological Health, Jeffrey Shuren, has declared that “these preliminary reports show a smarter FDA – an agency that recognizes both sides of our mission to protect and promote public health.” Further, Shuren stated that his “agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.”

Details of the proposed regulations include plans to streamline the medical device approval process for lower-risk novel devices which ordinarily cannot be cleared under the current guidelines due, at times, to the lack of a predicate device currently on the market, however do not warrant more rigorous premarket approval. According to the FDA, this regulation is an attempt to ease the burden on device manufacturers and shorten the timeline of the approval process of novel medical devices. This new regulation would allow a medical device developer to have a better understanding of the requirements set forth by the FDA and data required to get a new medical device approved.

Further, the new regulations would also create a new class of devices which would require clinical evidence establishing efficacy and safety be submitted before the product could be approved. The regulations would also provide greater communication to applicants on the front-end regarding the requirements for gaining approval of a medical device, thus avoiding unnecessary surprise and delays which are said to exist in the current system. The agency has declared that this regulation is intended to allow the medical device manufacturer to obtain predictability in what is expected of them in order to get their medical device approved.

Additionally, the agency seeks to increase the use of scientific experts outside of the agency, specifically by the use of web-based social medical technology, to create “Notice to the Industry” letters to more quickly communicate regulatory changes to those in the industry. It also intends to form a Center Science Council to oversee science-based decisions in order to support consistency in decision making within the agency. Also, the proposed regulations would attempt to foster information sharing with the public by creating a searchable online public database to provide information with regard to medical devices. This website would include summaries of agency review decisions, photographs and design schematics of approved devices, and up-to-date information about device labeling.

The proposed FDA regulations are not yet effective; in fact, the agency is currently seeking public comments on its proposals by inviting interested individuals to submit comments on the report. It is anticipated the public comment period will close within the next few months. After the public comment period has been completed, the agency will announce which regulations it intends to implement and will decide on the timeline for the implementation of these new regulations.