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)

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, 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