2010-19339. Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations; Availability; ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comment.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability for public comment of a two-volume set of documents entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.” The recommendations contained in these reports are preliminary. FDA has not made any decisions on specific changes to pursue. FDA is soliciting public input on the recommendations discussed in these reports, including the feasibility of implementation and potential alternatives. Once its assessment of public input and other necessary reviews are completed, FDA will announce which improvements it will implement, as well as projected timelines for implementation.

DATES:

Submit either electronic or written comments on the preliminary report by October 4, 2010.

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:

Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5447, Silver Spring, MD 20993-0002, 301-796-5678.

SUPPLEMENTARY INFORMATION:

I. Background

A. 510(k) Working Group

The premarket notification (510(k)) process for the review of medical devices was established in 1976, under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). With the exception of certain low-risk devices that are exempt from premarket submission requirements, a medical device that is first introduced into the market after May 28, 1976 (a postamendment device) may be legally marketed without an approved premarket approval application (PMA) if FDA concludes through review of a 510(k) submission that the device meets the comparative standard of “substantial equivalence” to a “predicate” device. Substantial equivalence may be determined by a comparison to a device that was legally marketed prior to May 28, 1976 (a preamendment device), to a device that has been reclassified from class III (high-risk) to class II or class I (medium- to low-risk), or to a device that has previously been cleared through the 510(k) process.

Since its inception, the 510(k) process has undergone a number of statutory changes. In addition, FDA has modified its implementation of the process to adapt to changing circumstances and accommodate the evolving medical device landscape. The current 510(k) program reflects the current statutory framework and FDA's implementation of that framework through regulation, guidance, and administrative practice.

The 510(k) program, as it currently exists, is intended to support FDA's public health mission by meeting two important goals: making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. In recent years, concerns have been raised within and outside of FDA about whether the current 510(k) program optimally achieves these goals.

In September 2009, CDRH convened an internal 510(k) Working Group as part of a two-pronged, comprehensive assessment of the 510(k) process. The other component of this assessment is an ongoing independent study by the Institute of Medicine, which is expected to conclude in the summer of 2011. The 510(k) Working Group was charged to evaluate the 510(k) program and explore actions CDRH could take to strengthen the program and improve the consistency of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority.

B. Task Force on the Utilization of Science in Regulatory Decision Making

CDRH uses science to guide its regulatory decision making across the total product life cycle of medical devices and radiation-emitting products. At any stage of that life cycle, CDRH may encounter new, unfamiliar, or unexpected information that may influence its thinking, expectations, and actions. To fulfill its mission to protect and promote the public health, CDRH must strike a balance between the ability to adapt its approach as necessary as new science emerges, and the desire to provide predictable regulatory pathways that foster innovation.

In September 2009, CDRH convened an internal Task Force on the Utilization of Science in Regulatory Decision Making to review how CDRH uses science in its regulatory decision making, and to make recommendations on how the Center can quickly incorporate new science—including evolving information, novel technologies, and new scientific methods—into its decision making, while also maintaining as much predictability as practical.

C. Preliminary Reports

FDA is making available for public comment a two-volume set of documents entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations.” Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” This preliminary report is intended to communicate preliminary findings and recommendations regarding the 510(k) program and actions CDRH might take to address identified areas of concern. Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.” This preliminary report is intended to communicate preliminary findings and recommendations regarding the incorporation of new scientific information into CDRH's decision making and actions CDRH might take to address identified areas of concern.

Interested persons are invited to comment on either or both of these preliminary reports. CDRH will consider comments received prior to finalizing the two reports and determining which, if any, recommendations to implement in their current or a modified form.

II. 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.

III. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.regulations.gov or http://www.fda.gov/​AboutFDA/​CentersOffices/​CDRH/​CDRHReports/​default.htm (select appropriate option from the menu).

Dated: July 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.