[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14903-14904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05763]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1003]
Center for Devices and Radiological Health: Experiential Learning
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration's (FDA) Center for Devices
and Radiological Health (CDRH or Center) is announcing the 2017
Experiential Learning Program (ELP). This training component is
intended to provide CDRH staff with an opportunity to understand the
policies, laboratory practices, patient perspective/input, quality
system management, and other challenges that impact the device
development life cycle. The purpose of this document is to invite
medical device industry, academia, and health care facilities, and
others to participate in this formal training program for CDRH's
employees, or to contact CDRH for more information regarding the ELP.
DATES: Submit either electronic or written requests for participation
in the ELP by dates specified in the ELP Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.
ADDRESSES: Submit either electronic requests to https://www.regulations.gov or written requests to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify requests with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993-0002, 240-
402-2246, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is responsible for helping to ensure the safety and
effectiveness of medical devices marketed in the United States.
Furthermore, CDRH assures that patients and providers have timely and
continued access to high-quality, safe, and effective medical devices.
For 2016-2017, CDRH has identified Partnering with Patients and
Promoting a Culture of Quality and Organizational Excellence as
strategic priorities, specifically having the perspective of our
stakeholders and understanding implementation of these within their
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institutions would provide great insight to FDA review staff. The
Center encourages applicants to consider including opportunities to
discuss patient perspective and meeting the challenges of quality
systems design and management as they contribute to the success of the
device development life cycle.
CDRH is committed to advancing regulatory science, providing
industry with predictable, consistent, transparent, and efficient
regulatory pathways, and helping to ensure consumer confidence in
medical devices marketed in the United States and throughout the world.
The ELP is intended to provide CDRH staff with an opportunity to
understand the policies, laboratory and manufacturing practices, and
the challenges addressing patient perspective/input, quality system
management, and other challenges that impact the device development
life cycle. This component is a collaborative effort to enhance
communication and facilitate the premarket review process. The Center
is committed to understanding current industry practices, innovative
technologies, regulatory impacts and needs, and how patient perspective
and quality systems management advances the development and evaluation
of innovative devices, and to monitoring the performance of marketed
devices.
These formal training visits are not intended for FDA to inspect,
assess, judge, or perform a regulatory function (e.g., compliance
inspection), but rather, they are an opportunity to provide CDRH review
staff a better understanding of the products they review, how they are
developed, the voice of the patient, challenges related to quality
systems development and management in the product life cycle, and how
medical devices fit into the larger health care system. CDRH is
formally requesting participation from companies, academia, and
clinical facilities, medical device incubators and accelerators, health
insurers, health technology assessment groups, and others, including
those that have previously participated in the ELP or other FDA site
visit programs.
CDRH encourages applicants to consider including opportunities to
discuss how patient perspective and effective quality systems
management contribute to the success of the device development life
cycle. Additional information regarding the CDRH ELP, including the
table of areas of interest, submission dates and deadlines, a sample
request, and an example of the site visit agenda, is available on
CDRH's Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm. The Center encourages
applicants to consider including opportunities to discuss patient
perspective and meeting the challenges of Quality Systems Design and
Management as they contribute to the success of the device development
life cycle.
II. CDRH ELP
A. Areas of Interest
In this training program, groups of CDRH staff will observe
operations in the areas of research, device development, in making
coverage decisions and assessments, incorporating patient information
and reimbursement, manufacturing, academia, and health care facilities.
The areas of interest for visits include various topics identified by
managers at CDRH. These areas of interest are listed publicly and are
intended to be updated quarterly.
To submit a proposal addressing one of the Center's training needs,
visit the link for the table of areas of interest to be addressed at:
http://www.fda.gov/ScienceResearch/ScienceCareerOpportunities/
UCM380676.htm
Once you have determined an area of interest to address in your ELP
proposal, follow the instructions in section III to properly fill out
the site visit request template and agenda provided at: http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and at: http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM487190.pdf.
B. Site Selection
CDRH will be responsible for CDRH staff travel expenses associated
with the site visits. CDRH will not provide funds to support the
training provided by the site to the ELP. Selection of potential
facilities will be based on CDRH's priorities for staff training and
resources available to fund this program. In addition to logistical and
other resource factors, all sites must have a successful compliance
record with FDA or another Agency with which FDA has a memorandum of
understanding (if applicable). If a site visit involves a visit to a
separate physical location of another firm under contract with the
site, that firm must agree to participate in the ELP and must also have
a satisfactory compliance history, and must be listed in the proposal
along with a Facility Establishment Identifier number (FEI #) if
applicable.
III. Request to Participate
Submit proposals for participation with the docket number found in
the brackets in the heading of this document. Received requests may be
seen in the Division of Dockets Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through Friday.
Additional information regarding the CDRH ELP, including a sample
request and an example of a site visit agenda and submission deadlines,
is available on CDRH's Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.
Dated: March 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05763 Filed 3-22-17; 8:45 am]
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