[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.
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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]
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