[Federal Register: December 18, 2009 (Volume 74, Number 242)] [Notices] [Page 67237-67238] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18de09-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 https://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
advance.
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 https://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.
SUPPLEMENTARY INFORMATION:
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
decisionmaking.
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
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
developed?
B. Adapting to Novel Technologies or Novel Uses of Existing
Technologies
(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 https://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 https://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]
BILLING CODE 4160-01-S
