FDA unveils new plan of action for 510(k) process

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The FDA unveiled a plan of action Jan. 19, containing 25 initiatives that the agency intends to implement during 2011 to improve the 510(k) market approval process for medical devices.

According to the agency, key actions include:

  • Streamlining the “de novo” review process for certain lower-risk medical devices;
  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the transparency of the review process; and
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

In September 2009, the FDA’s Center for Devices and Radiological Health (CDRH) set up two internal working groups to address concerns relating to the premarket notification process. The FDA reported that “industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and healthcare professionals argued that the review process wasn’t robust enough.” At the same time, CDRH asked the independent, nonprofit Institute of Medicine (IOM) to study the program. That review is still underway.

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 said it received 76 written comments to three public dockets from industry members, healthcare professional organizations, consumer groups, patient groups, third-party payors, 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 comments, 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 IOM 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.

“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the  de novo process,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed). “In addition, FDA’s plan drops or defers for IOM review many proposals that would have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits.

“The critical next step is how FDA implements the plan through guidances and regulations,” Ubl added.

“It is essential for regulators, industry and other stakeholders to work together to understand all of the implications associated with regulatory and sub-regulatory efforts,” according to the Medical Imaging & Technology Alliance (MITA). “While we are encouraged that there is a delay and reconsideration of those items determined most controversial, we are continuing to review other items of interest.”

The FDA’s full plan of action is available on its site.