Advertisement
News
Advertisement

Federal Register: Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regul...

Thu, 08/05/2010 - 4:31am
U.S. Food & Drug Administration

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

SOURCE

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading