[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, [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.
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.
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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