2011-25597. Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of draft standard operating procedures (SOPs) for a new “Network of Experts.” The draft SOPs describe a new process for staff at the Center for Devices and Radiological Health (CDRH, the center) to gain access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center.

DATES:

Submit either electronic or written comments on the report by November 7, 2011.

ADDRESSES:

See the SUPPLEMENTARY INFORMATION section for electronic access to the document. Submit electronic comments on the preliminary report to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Nada O. Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427.

SUPPLEMENTARY INFORMATION:

I. Background

In September 2009, the Task Force on the Utilization of Science in Regulatory Decision Making (Task Force) and the 510(k) Working Group were established to address critical challenges facing the Center and our external constituents. The 510(k) Working Group was charged with evaluating the premarket notification (510(k)) program and exploring actions CDRH can take to enhance our 510(k) decision making. The Task Force was charged with making recommendations on how the Center can quickly incorporate new science—including evolving information, novel technologies, and new scientific methods—into its decision making in as predictable a manner as is practical. The 510(k) Working Group and Task Force made recommendations and then developed a plan of action for implementation of these 510(k) and Science Recommendations. This plan identified internal and administrative matters to be addressed and included an action item of leveraging external expertise.

II. The Draft SOPs

FDA is announcing the availability of two draft SOPs, one entitled, “Network of Experts—Expert Utilization Standard Operating Procedure” and one entitled, “Network of Experts—Expert Enrollment Standard Operating Procedure.” The purpose of the draft SOPs is to develop a network of external experts to appropriately and efficiently leverage external scientific expertise, and to describe the process for staff engagement with external experts. The network will be built on a series of agreements with external organizations including professional, scientific, and medical organizations and academic institutions. The draft SOPs describe CDRH processes for providing CDRH staff with access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within CDRH. The network of experts is designed to broaden CDRH's exposure to scientific viewpoints, but not to provide external policy advice or opinions.

CDRH has a knowledgeable, professional internal cadre of scientific expertise, including over 800 scientists, engineers, and clinicians. Despite this internal resource, it is unrealistic to expect CDRH staff to encompass all of the applicable expertise and experience necessary to fulfill our mission given the rapidly growing variety and complexity of medical devices. This is particularly true when it comes to new and emerging fields of science and pioneering technologies. In these areas, it is often necessary for our experts to gain further scientific understanding from external sources. The Network of Experts will facilitate this exchange.

In developing the draft SOPs, CDRH assessed best practices. CDRH is also beginning a pilot project to use these draft SOPs on a trial basis. Experience from the pilot, along with comments on this notice, will further assist the agency in determining whether the draft SOPs should be improved going forward.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons interested in obtaining a copy of the draft SOPs may do so by using the Internet. The draft SOP entitled: “Network of Experts—Expert Utilization Standard Operating Procedure” can be obtained from FDA's Web site at http://www.fda.gov/​AboutFDA/​CentersOffices/​CDRH/​CDRHReports/​ucm271521.htm. The draft SOP entitled: “Network of Experts—Expert Enrollment Standard Operating Procedure” can be obtained from FDA's Web Site at http://www.fda.gov/​AboutFDA/​CentersOffices/​CDRH/​CDRHReports/​ucm271523.htm. The draft SOPs are also available from http://www.regulations.gov and can be located using the docket number found in brackets in the heading of this document.

Dated: September 29, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.