82 FR 14903 - Center for Devices and Radiological Health: Experiential Learning Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 55 (March 23, 2017)

Page Range		14903-14904
FR Document		2017-05763

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.

Federal Register, Volume 82 Issue 55 (Thursday, March 23, 2017)

[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14903-14904]
From the Federal Register Online  [www.thefederalregister.org]
[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

[[Page 14904]]

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]
 BILLING CODE 4164-01-P

14904 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices

institutions would provide great insight scienceresearch/ with a Facility Establishment Identifier
to FDA review staff. The Center sciencecareeropportunities/ number (FEI #) if applicable.
encourages applicants to consider ucm380676.htm. The Center encourages
III. Request to Participate
including opportunities to discuss applicants to consider including
patient perspective and meeting the opportunities to discuss patient Submit proposals for participation
challenges of quality systems design and perspective and meeting the challenges with the docket number found in the
management as they contribute to the of Quality Systems Design and brackets in the heading of this
success of the device development life Management as they contribute to the document. Received requests may be
cycle. success of the device development life seen in the Division of Dockets
CDRH is committed to advancing cycle. Management (see ADDRESSES) between
regulatory science, providing industry 9 a.m. and 4 p.m., Monday through
with predictable, consistent, II. CDRH ELP Friday.
transparent, and efficient regulatory A. Areas of Interest Additional information regarding the
pathways, and helping to ensure CDRH ELP, including a sample request
consumer confidence in medical In this training program, groups of and an example of a site visit agenda
devices marketed in the United States CDRH staff will observe operations in and submission deadlines, is available
and throughout the world. The ELP is the areas of research, device on CDRH’s Web site at: http://
intended to provide CDRH staff with an development, in making coverage www.fda.gov/scienceresearch/
opportunity to understand the policies, decisions and assessments, sciencecareeropportunities/
laboratory and manufacturing practices, incorporating patient information and ucm380676.htm.
and the challenges addressing patient reimbursement, manufacturing,
Dated: March 17, 2017.
perspective/input, quality system academia, and health care facilities. The
Leslie Kux,
management, and other challenges that areas of interest for visits include
various topics identified by managers at Associate Commissioner for Policy.
impact the device development life [FR Doc. 2017–05763 Filed 3–22–17; 8:45 am]
cycle. This component is a collaborative CDRH. These areas of interest are listed
effort to enhance communication and publicly and are intended to be updated BILLING CODE 4164–01–P

facilitate the premarket review process. quarterly.
The Center is committed to To submit a proposal addressing one
of the Center’s training needs, visit the DEPARTMENT OF HEALTH AND
understanding current industry HUMAN SERVICES
practices, innovative technologies, link for the table of areas of interest to
regulatory impacts and needs, and how be addressed at: http://www.fda.gov/ Food and Drug Administration
patient perspective and quality systems ScienceResearch/
management advances the development ScienceCareerOpportunities/ [Docket No. FDA–2017–D–0198]
and evaluation of innovative devices, UCM380676.htm
Once you have determined an area of Delayed Graft Function in Kidney
and to monitoring the performance of Transplantation: Developing Drugs for
marketed devices. interest to address in your ELP proposal,
follow the instructions in section III to Prevention; Draft Guidance for
These formal training visits are not
properly fill out the site visit request Industry; Availability
intended for FDA to inspect, assess,
judge, or perform a regulatory function template and agenda provided at: http:// AGENCY: Food and Drug Administration,
(e.g., compliance inspection), but rather, www.fda.gov/downloads/ HHS.
they are an opportunity to provide ScienceResearch/ ACTION: Notice of availability.
CDRH review staff a better ScienceCareerOpportunities/
understanding of the products they UCM392988.pdf and at: http:// SUMMARY: The Food and Drug
review, how they are developed, the www.fda.gov/downloads/ Administration (FDA or Agency) is
voice of the patient, challenges related ScienceResearch/ announcing the availability of a draft
to quality systems development and ScienceCareerOpportunities/ guidance for industry entitled ‘‘Delayed
management in the product life cycle, UCM487190.pdf. Graft Function in Kidney
and how medical devices fit into the Transplantation: Developing Drugs for
B. Site Selection Prevention.’’ The purpose of this
larger health care system. CDRH is
formally requesting participation from CDRH will be responsible for CDRH guidance is to assist sponsors in the
companies, academia, and clinical staff travel expenses associated with the clinical development of drugs for the
facilities, medical device incubators and site visits. CDRH will not provide funds prevention of delayed graft function
accelerators, health insurers, health to support the training provided by the (DGF) in kidney transplantation.
technology assessment groups, and site to the ELP. Selection of potential DATES: Although you can comment on
others, including those that have facilities will be based on CDRH’s any guidance at any time (see 21 CFR
previously participated in the ELP or priorities for staff training and resources 10.115(g)(5)), to ensure that the Agency
other FDA site visit programs. available to fund this program. In considers your comment on this draft
CDRH encourages applicants to addition to logistical and other resource guidance before it begins work on the
consider including opportunities to factors, all sites must have a successful final version of the guidance, submit
discuss how patient perspective and compliance record with FDA or another either electronic or written comments
effective quality systems management Agency with which FDA has a on the draft guidance by June 21, 2017.
contribute to the success of the device memorandum of understanding (if
sradovich on DSK3GMQ082PROD with NOTICES

ADDRESSES: You may submit comments
development life cycle. Additional applicable). If a site visit involves a visit as follows:
information regarding the CDRH ELP, to a separate physical location of
including the table of areas of interest, another firm under contract with the Electronic Submissions
submission dates and deadlines, a site, that firm must agree to participate Submit electronic comments in the
sample request, and an example of the in the ELP and must also have a following way:
site visit agenda, is available on CDRH’s satisfactory compliance history, and • Federal eRulemaking Portal: http://
Web site at: http://www.fda.gov/ must be listed in the proposal along www.regulations.gov. Follow the

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Document Created: 2017-03-23 02:46:01
Document Modified: 2017-03-23 02:46:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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]
FR Citation		82 FR 14903

82 FR 14903 - Center for Devices and Radiological Health: Experiential Learning Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 55 (March 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration