[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Pages 7220-7221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2916]



Food and Drug Administration

[Docket No. FDA-2011-N-0063]

Medical Device Innovation Initiative; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


[[Page 7221]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document for public comment entitled ``Medical Device 
Innovation Initiative'' (the report). The report proposes potential 
actions for FDA's Center for Devices and Radiological Health (CDRH) to 
facilitate the development, assessment, and regulatory review of 
innovative medical devices.

DATES: Submit either electronic or written comments on the report by 
April 11, 2011.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the report.
    Submit electronic comments on the 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: Jonathan Sackner-Bernstein, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 5410, Silver Spring, MD 20993, 301-
796-5420, e-mail: [email protected].


I. Background

    The United States is the global leader in medical device innovation 
and CDRH is committed to assuring that American patients have timely 
access to important new technologies and next-generation products 
without compromising their safety. Each year, millions of American 
patients benefit from innovative medical devices that reduce suffering, 
treat previously untreatable conditions, extend lives, and improve 
public health.
    CDRH is responsible for advancing public health and facilitating 
innovation to help bring novel technologies to market and make the 
medical devices that are already on the market safer and more 
effective. Recently, CDRH announced 25 actions it will take in 2011 to 
strengthen its most widely-used premarket review process--the 510(k) 
program--and increase its use of emerging science to foster innovation 
and improve the predictability, consistency, and transparency of its 
decisionmaking.\1\ These actions will not only improve the safety of 
medical devices but also increase the ability of innovating companies 
to attract investors, estimate costs, and more quickly bring products 
to market.

    \1\ See ``510(k) and Science Report Recommendations: Summary and 
Overview of Comments and Next Steps,'' available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239449.pdf; and ``Plan of Action for Implementation of 510(k) and 
Science Recommendations,'' available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf.

    The report proposes actions CDRH might take to help accelerate the 
development and regulatory evaluation of innovative devices safely and 
based on sound science. These actions are as follows:
     Facilitate the development and regulatory evaluation of 
innovative medical devices;
     Strengthen the U.S. research infrastructure and promote 
high-quality regulatory science; and
     Prepare for and respond to transformative innovative 
technologies and scientific breakthroughs.
    Part of the Medical Device Innovation Initiative would consider the 
creation of a special Innovation Pathway intended to provide earlier 
investment of CDRH time and resources in devices that are true 
pioneering technologies and that have the potential to revolutionize 
patient care or health care delivery. By front-loading critical 
aspects, such as identifying clinical endpoints and key scientific 
questions, and seeking advice from external experts, the Innovation 
Pathway would facilitate a more efficient regulatory review process for 
transformative devices.
    CDRH is seeking public comment on the proposals contained in the 
report through an open public docket and will be hosting a public 
meeting to solicit stakeholder feedback at our White Oak, MD campus on 
March 15, 2011. Therefore, elsewhere in this issue of the Federal 
Register, FDA is announcing a public meeting entitled ``CDRH's Medical 
Device Innovation Initiative Public Workshop.''
    CDRH requests public comments on the report in general, as well as 
the following specific questions and topics:
    1. The eligibility criteria for the Innovation Pathway.
    2. How should CDRH determine what types of technology should be 
allowed into the Innovation Pathway and at what point they should no 
longer be accepted as innovative products? For example, under Expedited 
Review, if multiple applications for the same type of device offering 
comparable advantage over existing approved alternatives have been 
granted expedited review, they are reviewed with priority assigned on a 
first-in-first-reviewed basis for each review cycle. Furthermore, if 
one of these applications is approved, the remaining expedited 
applications will retain their expedited status until a final decision 
is rendered after which point no additional devices of this type will 
be granted expedited review status. Should the same process be used for 
the Innovation Pathway?
    3. What are the appropriate timeframes for review of submissions 
under the Innovation Pathway? Should final regulatory submissions from 
devices developed under the Innovation Pathway be reviewed on a 
shortened timeframe? For comparison, the review times to which CDRH has 
currently committed under the Medical Device User Fee and Modernization 
Act are available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109319.htm.
    4. Criteria for clinical test center certification.
    5. Candidates for interagency or public-private partnerships to 
foster medical device innovation.
    6. Other actions CDRH should take to facilitate the development, 
assessment, and regulatory review of innovative medical devices while 
assuring their safety and effectiveness.

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 report at http://www.regulations.gov or http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm241095.htm.

    Dated: February 4, 2011.
Nancy K. Stade,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 2011-2916 Filed 2-8-11; 8:45 am]