FDA Plans Update of Medical Device Review Process

(Tomomarusan/Wikimedia Commons)

The U.S. Food and Drug Administration (FDA) has released a plan with 25 actions it intends to implement in 2011, which it says will improve the path to market for many medical devices. The new procedures affect the “510(k) process,” named for the section of FDA’s enabling legislation that applies to medical device approval.

Before marketing most lower-risk medical products such as some catheters or diagnostic imaging devices, manufacturers must provide the FDA with a 510(k) pre-market notification. In their submissions, companies need to demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

FDA says the new rules will streamline the review process for certain innovative, lower-risk medical devices, called de novo reviews. The improvements are also expected to clarify when FDA requires clinical data in a pre-market submission, which FDA believes will increase the efficiency and transparency of the review process.

FDA is establishing as well a new Center Science Council of senior agency experts, which is expected to result in faster and more consistent science-based decision making.

In 2009, two internal committees in FDA’s Center for Devices and Radiological Health (CDRH) issued reports indicating much of the medical device industry considered the 510(k) process was unpredictable, inconsistent, and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. FDA also held public meetings in four cities and received 76 written comments from three public dockets.

At the same time, CDRH also asked the independent Institute of Medicine (IOM) — part of the National Academies — to study the program. That review is still underway, but IOM will be given a chance to provide feedback before FDA makes a final decision. Another public meeting in April is also planned.

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