FDA to Improve Medical Device Reviews

The U.S. Food and Drug Administration (FDA) announced that it plans on improving the most common review path for <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices, with goals that include fostering device innovation and protecting patient safety.

The FDA just unveiled its plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. Its three key actions are:

• Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,

• Clarifying when clinical data should be submitted in a pre-market submission, guidance that will increase the efficiency and transparency of the review process,

• Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision-making.

These actions, said the FDA, will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).

Before marketing most lower risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a pre-market notification submission.

These submissions are known as 510(k)s for the section of the Federal Food, Drug, and Cosmetic Act that describes this notification requirement. Generally, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

In September 2009, CDRH set up two internal working groups to address concerns relating to the pre-market notification process—industry argued that the 510(k) process was unpredictable, inconsistent, and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway.

The CDRH sought public input during both the development and review of the two internal reports. The center held two public meetings in the Washington area and separate “town hall” meetings in Minneapolis, Boston, and Los Angeles. The FDA also received 76 written comments to three public dockets from industry members, health care professional organizations, consumer groups, patient groups, third-party payers, venture capital groups, agency staff, trial lawyers, foreign regulatory bodies, law firms, individual members of the public, consulting firms, and academic institutions.

The two working groups issued 55 recommendations in August 2010. After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training. CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision, and is planning for a public meeting in April to seek additional feedback on two other recommendations.

Dr. Shuren just announced the action plan in an open letter to the public. “We look forward to implementing these changes in support of our overall mission: improving the health of the American public,” he said.

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