[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46272-46274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1088]


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 a new component of 
the Experiential Learning Program (ELP) identified as the 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 
apply 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 September 8, 2014.

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. 66, Rm. 4448, Silver Spring, MD 20993-0002, 301-796-6965, 
FAX: 301-827-3079, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    CDRH is responsible for ensuring 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 and safe radiation-
emitting products. In support of this mission, the Center launched 
various training and development initiatives to enhance performance of 
its staff involved in regulatory review and

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in the premarket review process. One of these initiatives, the ELP 
Pilot, was launched in 2012 and fully implemented on April 2, 2013 (see 
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 a mechanism 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. 
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. ELP General Training Program

A. ELP General Training Component

    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...............  Decisionmaking process for
                                          biocompatibility test
                                          selection; 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);
                                          drug delivery products.
Emerging manufacturing methods.........  3-D printing; additive
                                          manufacturing; additional or
                                          unique validation and
                                          verification activities.
Management of clinical trials for        Understanding clinical trial
 medical devices.                         infrastructure, roles,
                                          responsibilities, and
                                          relationships with other
                                          organizations involved in the
                                          management and conduct of
                                          clinical trials; challenges
                                          encountered in obtaining
                                          regulatory approval and
                                          successfully executing a
                                          clinical trial; issues related
                                          to early feasibility studies;
                                          institutional review boards;
                                          clinical research
                                          organizations.
Reprocessing and sterilization.........  Reprocessing challenges in the
                                          manufacturing or clinical
                                          environment; validation of
                                          reprocessing or sterilization
                                          instructions; simulated use
                                          testing; unique sterilization
                                          methods (e.g., use of flexible
                                          bags, 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 diagnostic     Preanalytical devices (i.e.
 devices.                                 blood tubes), pathogen
                                          collection devices, micro
                                          collection/transport devices;
                                          general reagents, manual
                                          reagents; general assays,
                                          common point-of-care devices.
Instrument training of medical devices   Hands-on instrument and system
 (manufacturer or clinical laboratory).   training; clinical implication
                                          of common laboratory testing.
Quality system in manufacturing          Observation of implemented
 environments based on 21 CFR part 820.   quality systems practices
                                          based on current good
                                          manufacturing practices.
------------------------------------------------------------------------

B. Site Selection

    The Center 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 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 for Participation

    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, and will be posted to the 
docket at http://www.regulations.gov.
    The proposal should include a description of your facility relative 
to focus areas described in table 1or 2. Please include the Area of 
Interest (see table 1or 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://

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www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: July 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18662 Filed 8-6-14; 8:45 am]
BILLING CODE 4164-01-P