On Wednesday, January 19, 2011, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released its 510(k) and Science Report Recommendations outlining actions that the agency will implement in 2011 to improve the 510(k) process.

In response to concerns raised by industry, consumers, third-party payers, and health providers, in September 2009, CDRH commissioned both internal and external evaluations of the 510(k) process to evaluate how well the 510(k) program was meeting its two public health goals of (1) facilitating innovation and (2) assuring that medical devices are safe and effective. The agency established the 510(k) Working Group (Working Group) and the Task Force of the Utilization of Science (Task Force) to address these issues, as well as requested that an outside organization, the Institute of Medicine (IOM), conduct an independent evaluation of the 510(k) program. The IOM's report is expected in the summer of 2011.

The Working Group was charged with evaluating how well the 510(k) program was meeting its two public health goals and potential actions to assist the agency in meeting these goals. The Task Force was charged with addressing how CDRH can incorporate new science into its decision making. The Working Group and Task Force issued reports in August 2010 outlining 55 recommendations for the 510(k) program. In developing the Working Group and Task Force reports and receiving the medical device community's feedback on these reports, the agency held two public meetings, three town hall meetings, and had three open public dockets.

In follow-up to comments received on the 55 recommendations in the Working Group and Task Force reports, the FDA's January 19 announcement outlines CDRH's plan for implementing 25 initiatives in 2011 for improving the 510(k) program. CDRH appears to have carefully considered the community's comments on each of the recommendations in deciding which initiatives to implement. Key initiatives which are likely to have the most significant impact on the device industry are outlined below.

Streamlining the de novo classification process. CDRH plans to issue guidance outlining modifications to the de novo classification process to make this process more efficient. Dr. Jeffrey Shuren, Director of the CDRH, clarified during the media briefing that the FDA is considering ways to determine whether a device would qualify for downclassification earlier in the process, and further streamline the process by requiring only brief 510(k) submissions instead of a complete 510(k) notice. Dr. Shuren noted that these modifications are still being discussed, and the public will have the opportunity to comment on the agency's proposed recommendations.

Providing additional guidance on pre-submission communications. The agency will provide pre-submission interactions guidance to enhance the quality of pre-submission interactions between industry and CDRH and supplement the existing guidance on pre- Investigational Device Exemption (IDE) meetings.

Modifications to 510(k) devices. The agency will issue new guidance to clarify which changes require the submission of a new 510(k) notice and which modifications are eligible for a Special 510(k) notice.

Use of multiple predicates to establish substantial equivalence. The agency clarified that the term "split predicate" refers to cases where one predicate is used for intended use and another for technological characteristics, and the new device raises different type of safety and efficacy questions. The agency clarified that the use of a true split predicate is inconsistent with the 510(k) regulatory standard, but emphasized that it supports the use of multiple predicates in establishing substantial equivalence. CDRH stated that as the term "split predicate" is used inconsistently by different groups, the agency will no longer use this term going forward.

  • The agency intends to further investigate the Working Group observation of increased adverse events for devices that cite to more than five predicates to determine whether there is support for this initial finding.

Establish a Center Science Council. The agency will establish a council of senior FDA experts to assure timely and consistent science-based decision making. The council will oversee the development of a procedure for responding to new scientific information, periodically audit 510(k) reviewed devices to assess adequacy, accuracy and consistency; and establish an internal team of clinical trial experts to provide support and advice for CDRH and prospective IDE applicants.

Clinical data. CDRH will issue guidance clarifying when clinical data should be submitted in a premarket submission, as well as guidance to improve the quality and performance of clinical trials.

Develop a network of external experts. CDRH will develop a network of external experts to provide outside scientific expertise. CDRH will provide a procedure outlining parameters for discussions with external experts.

Notice to industry. CDRH will develop a process for informing industry when the FDA has changed the regulatory expectations for devices based on new scientific evidence. CDRH will develop a procedure regarding the parameters for issuing these letters.

In addition to these initiatives, the agency will hold a public meeting in April 2011 to discuss establishing a database of current device labeling and a database which contains photographs and schematics of devices.

The FDA also indicated it was referring seven of the recommendations from the Working Group and Task Force reports to the IOM for consideration as part of IOM's independent review of the 510(k) program. The agency will consider any comments the IOM provides prior to deciding whether to implement these particular recommendations. The seven recommendations referred to the IOM for review are:

  • Consolidating the terms "indications for use" and "intended use;"
  • Consideration of off-label use when determining the intended use of a device;
  • Issuing guidance regarding when a device should no longer be available for use as a predicate;
  • Issuing a regulation on CDRH's rescission authority;
  • Requiring that manufacturers keep one unit of a device available for the FDA evaluation;
  • Creating a class IIb category of devices for which clinical information, manufacturing information, or postmarket evaluation would typically be necessary to support a determination of substantial equivalence; and
  • Requiring postmarket surveillance studies as a condition of clearance for certain devices.

The documents outlining CDRH's plan for implementing the 25 initiatives and its consideration of the recommendations from the Working Group and Task Force can be accessed with the links below. CDRH plans to begin implementing these initiatives by the end of March 2011.

510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps

Plan of Action for Implementation of 510(k) and Science Recommendations

Letter From the Center Director