[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Pages 67237-67238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30114]



Food and Drug Administration

[Docket No. FDA-2009-N-0575]

Incorporation of New Science Into Regulatory Decisionmaking 
Within the Center for Devices and Radiological Health; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled: ``Incorporation of New Science Into Regulatory 
Decisionmaking Within the Center for Devices and Radiological Health.'' 
The purpose of the public meeting is to identify strategies and means 
for incorporating new science into the regulatory decisionmaking 
process within the agency's Center for Devices and Radiological Health 
(CDRH). New science may include novel technologies or novel uses of 
existing technologies, evolving information and knowledge, or new 
methods to support decisionmaking. FDA is seeking input on a number of 
specific questions regarding how CDRH should anticipate and respond to 
new or evolving scientific knowledge in a manner that is consistent 
with our mission to protect and promote the public health, and requests 
comments on this topic.
    Dates and Time: The public workshop will be held on February 9, 
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting 
must register by 5 p.m. on February 3, 2010.
    Location: The public meeting will be held at the Hilton Washington 
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Maggie Dietrich, Food and Drug Administration, 
Center for Devices and Radiological Health, 10903 New Hampshire Ave., 
Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002, 301-796-5094, FAX: 
301-847-8510, e-mail: maggie.dietrich@fda.hhs.gov.
    Registration: Register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate 
meeting from the list). Provide complete contact information for each 
attendee, including name, title, affiliation, address, e-mail, and 
telephone number. Registration requests should be received by February 
3, 2010. Registration is free and will be on a first-come, first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once they 
have been accepted. Onsite registration on the day of the public 
meeting will be provided on a space-available basis beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Maggie Dietrich (see Contact Person) at least 7 days in 
    Comments: FDA is holding this public meeting to obtain information 
on a number of specific questions regarding how CDRH should anticipate 
and respond to new or evolving scientific knowledge in a manner that is 
consistent with FDA's mission to protect and promote the public health. 
The deadline for submitting comments regarding this public meeting is 
February 24, 2010.
    Regardless of attendance at the public meeting, interested persons 
may submit written or electronic comments. Submit written comments to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Please also indicate the specific question(s) 
addressed. (See section II 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.


I. Background

    FDA's CDRH uses science to guide our regulatory decisions, 
including those related to premarket approval or clearance, postmarket 
oversight, and compliance.
    CDRH faces unique challenges in that the products we regulate are 
constantly changing, either through incremental or disruptive advances. 
Simultaneously, our understanding of the products we oversee is subject 
to change as we obtain new scientific information or develop new 
methods to assess existing data.
    Given the ever-changing environment in which we operate, CDRH's 
regulatory decisionmaking process must be able to adapt as science 
evolves and as new information emerges about the risks or benefits of 
particular medical devices or radiation-emitting electronic products. 
For example, in some cases, new information gathered about the risk-
benefit profile of a device on the market may justify requiring 
additional data on similar types of devices during premarket review, in 
order to provide sufficient confidence in the product's safety and 
effectiveness. At the same time, the center seeks to foster innovation 
by providing industry with a reasonable degree of predictability in our 
regulatory pathways. Determining the optimal way to anticipate and 
respond to new science is an important challenge, and the center seeks 
public input on how to best address it.
    CDRH has formed an internal Task Force on Utilization of New 
Science in Regulatory Decisionmaking to review how the center uses 
science in our regulatory decisionmaking process, and to make 
recommendations for enhancements. The principal goals of the Task Force 
are: (1) To propose systems that will allow CDRH to be ``predictably 
adaptive'' to new science; and (2) to identify proactive steps that 
CDRH can take to keep staff abreast of new science and increase our 
technical competence and analytic capability in order to enhance our 
    The notion of ``predictable adaptability'' refers to having the 
flexibility to appropriately respond to changes in science, while doing 
so through a reasonably consistent process. Given that scientific 
knowledge is continually changing, the model of being ``predictable'' 
by always requiring the same type and level of scientific evidence to 
justify decisions will not necessarily suffice. As the scientific 
landscape changes, the kind of information we need in order to make 
well-supported decisions may change. In the past, CDRH has sometimes 
incorporated new science into our regulatory decisionmaking on an ad 
hoc, non-transparent basis. Such an approach can result in inconsistent 
regulatory expectations and less predictable decisionmaking.
    CDRH seeks to move toward a different model of predictability: 
Creating and adhering to clear procedures for adapting to new science, 
and applying a consistent rationale for doing so in as timely and 
transparent a manner as is appropriate and feasible. In order to 
achieve this goal, the center

[[Page 67238]]

will need to identify how and when to adapt to new science, with a full 
consideration of the nature of the science itself, public health 
implications, and our statutory and regulatory framework.

II. Public Meeting

    As one step towards establishing the center's approach for 
incorporating new science in regulatory decisionmaking, CDRH will hold 
a public meeting to discuss the issues the Task Force is considering. 
The objective of the meeting will be to hear input on these issues from 
a broad range of external constituencies, including industry 
representatives, consumer and patient advocates, academic experts, 
other members of Government, and the general public.
    To focus the center's strategies, CDRH requests feedback related to 
the following questions, which will serve as the basis for discussion 
at the public meeting:

A. Adapting to New Scientific Information

    (1) When CDRH gains new scientific information about a particular 
product or type of product, what should the criteria be for changing 
CDRH's expectations of the evidence necessary for pre- or postmarket 
regulatory decisions, keeping in mind our mission to protect and 
promote the public health, as well as our statutory and regulatory 
framework? What are potential ``triggers'' for making such changes?
    (2) When such changes are warranted, how should the center 
communicate them to industry, consumers, and other external 
constituencies? Should CDRH have a new regulatory paradigm for 
communicating with outside parties?
    (3) When such changes are warranted, how should CDRH apply them to 
devices currently under review?
    (4) When such changes are warranted, how should CDRH apply them to 
products currently on the market? For example, how should CDRH treat 
``first-generation'' products as new and improved versions are 

B. Adapting to Novel Technologies or Novel Uses of Existing 

    (1) Assessing the safety and effectiveness of a novel technology 
can be challenging because the extent of information on and the level 
of understanding of the technology's risk-benefit profile or 
manufacturing process is less mature than that of a technology for 
which there is extensive ``real-world'' experience. What steps should 
CDRH take to assure that novel technologies or novel uses of existing 
technologies are safe and effective, without creating barriers to 
innovation, keeping in mind our statutory and regulatory framework?

C. Enhancing CDRH's Technical Competence and Analytical Capability

    (1) With current resources, what proactive steps should CDRH take 
to address gaps in staff-members' knowledge about new science and 
reduce uncertainty in science-based regulatory decisionmaking?
    During the meeting, there will be a moderated discussion between 
CDRH staff and invited experts from the private and public sectors 
about the questions presented in this document. The invited 
participants will not be asked to develop consensus recommendations, 
but rather to provide their individual perspectives. The topics for 
discussion will be presented in conjunction with hypothetical case 
studies for consideration. There will also be an opportunity for 
general attendees to provide feedback on the discussion topics during 
periodic open sessions.
    In advance of the meeting, additional information, including the 
case studies, will be made available on the Internet. This information 
will be placed on file in the public docket (docket number found in 
brackets in the heading of this document), which is available at http://www.regulations.gov. This information will also be available on FDA's 
Medical Devices Web site at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate 
meeting from the list), along with the agenda for the meeting.
    Transcripts: Transcripts of the public meeting may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public meeting at a cost of 10 
cents per page. A transcript of the public meeting will be available on 
the Internet at http://www.regulations.gov.

    Dated: December 11, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-30114 Filed 12-17-09; 8:45 am]