
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70821-70822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0986]


Center for Devices and Radiological Health: Experiential Learning 
Program; General Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Devices and 
Radiological Health (CDRH or Center) is announcing the 2015 
Experiential Learning Program (ELP) General Training Program. This 
training component is intended to provide CDRH staff with an 
opportunity to understand the policies, laboratory practices, and 
challenges faced in broader disciplines that impact the device 
development life cycle. The purpose of this document is to invite 
medical device industry, academia, and health care facilities to 
request to participate in this formal training program for FDA's 
medical device review staff, or to contact CDRH for more information 
regarding the ELP General Training Program.

DATES: Submit either an electronic or written request for participation 
in the ELP General Training Program by December 16, 2015.

ADDRESSES: Submit either electronic requests to http://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 proposals with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5232, Silver Spring, MD 20993-0002, 301-796-6965, 
FAX: 301-827-3079, Latonya.powell@fda.hhs.gov.

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. 
In support of this mission, the Center launched various training and 
development initiatives to enhance performance of its staff involved in 
regulatory review and in the premarket review process. One of these 
initiatives, the ELP Pilot, was launched in 2012 and fully implemented 
on April 2, 2013 (78 FR 19711).
    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 General Training Program component is intended to provide CDRH 
staff with an opportunity to understand the policies, laboratory 
practices, and challenges faced in broader disciplines that impact the 
device development life cycle. This component is a collaborative effort 
to enhance communication and facilitate the premarket review process. 
Furthermore, CDRH is committed to understanding current industry 
practices, innovative technologies, regulatory impacts, and regulatory 
needs.
    These formal training visits are not intended for FDA to inspect, 
assess,

[[Page 70822]]

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. Through this notice, 
CDRH is formally requesting participation from companies, academia, and 
clinical facilities, including those that have previously participated 
in the ELP or other FDA site visit programs.

II. CDRH ELP General Training Program

A. Areas of Interest

    In this training program, groups of CDRH staff will observe 
operations at research, manufacturing, academia, and health care 
facilities. The focus areas and specific areas of interest for visits 
may include the following:

         Table 1--Areas of Interest--Office of Device Evaluation
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            Focus area                   Specific areas of interest
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Biocompatibility testing..........  Decision making process for
                                     biocompatibility evaluation and
                                     test selection (if needed);
                                     considerations for use of animal
                                     testing vs. in vitro testing;
                                     sample preparation of nanoscale,
                                     bioabsorbable, and in situ
                                     polymerized materials; evaluation
                                     of color additives.
Combination products..............  Devices coated with drug(s) or
                                     biologic(s); drug/biologic delivery
                                     products.
Emerging manufacturing methods....  3-D printing; additive
                                     manufacturing; additional or unique
                                     validation and verification
                                     activities.
Management of clinical trials for   Conducting clinical trials,
 medical devices.                    overcoming common obstacles to
                                     starting and completing clinical
                                     trials, and interacting with
                                     various other stakeholders;
                                     preparing applications to request
                                     approval to conduct Investigational
                                     Device Exemption (IDE) clinical
                                     studies and responding to feedback
                                     received from FDA.
Reprocessing and sterilization....  Reprocessing challenges in clinical
                                     environment, including techniques
                                     for understanding and incorporating
                                     these challenges from the clinical
                                     environment to labeling and
                                     validation studies; techniques for
                                     validating cleaning, disinfection,
                                     or sterilization instructions;
                                     challenges in validating cleaning,
                                     disinfection, or sterilization
                                     instructions; simulated use
                                     testing, particularly for
                                     validating sterilization methods
                                     and instructions; unique
                                     sterilization methods (e.g., use of
                                     flexible bags, mixed sterilants
                                     sound waves, ultraviolet light,
                                     microwave radiation).
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  Table 2--Areas of Interest--Office of In Vitro Diagnostic Devices and
                           Radiological Health
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            Focus area                   Specific areas of interest
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Manufacturing of in vitro           Pre-analytical devices (i.e., blood
 diagnostic devices.                 tubes), pathogen collection
                                     devices, micro collection/transport
                                     devices; general reagents, manual
                                     reagents; general assays, common
                                     point-of-care devices.
Instrument training of medical      Hands-on instrument and system
 devices (manufacturer or clinical   training; clinical implication of
 laboratory).                        common laboratory testing; hands on
                                     familiarization of medical imaging
                                     equipment in a hospital setting.
Quality system in manufacturing     Observation of implemented quality
 environments based on 21 CFR part   systems practices based on current
 820.                                Good Manufacturing Practices; the
                                     manufacturing of medical imaging or
                                     therapeutic radiology technologies.
------------------------------------------------------------------------

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 this ELP General Training Program. 
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 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 General Training 
program and must also have a satisfactory compliance history.

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.
    The proposal should include a description of your facility relative 
to focus areas described in tables 1 or 2. Please include the Area of 
Interest (see tables 1 or 2) that the site visit will demonstrate to 
CDRH staff, a contact person, site visit location(s), length of site 
visit, proposed dates, and maximum number of CDRH staff that can be 
accommodated during a site visit. Proposals submitted without this 
minimum information will not be considered. In addition, please include 
an agenda outlining the proposed training for the site visit. A sample 
request and agenda are available on the ELP Web site at http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28857 Filed 11-13-15; 8:45 am]
BILLING CODE 4164-01-P


