
[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Notices]               
[Page 47307-47308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au10-79]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0348]

 
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; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comment.

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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

[[Page 47308]]

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.
[FR Doc. 2010-19339 Filed 8-4-10; 8:45 am]
BILLING CODE 4160-01-S

