80 FR 70821 - Center for Devices and Radiological Health: Experiential Learning Program; General Training Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 220 (November 16, 2015)

Page Range		70821-70822
FR Document		2015-28857

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.

Federal Register, Volume 80 Issue 220 (Monday, November 16, 2015)

[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70821-70822]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
Focus area Specific areas of interest
------------------------------------------------------------------------
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).
------------------------------------------------------------------------

Table 2--Areas of Interest--Office of In Vitro Diagnostic Devices and
Radiological Health
------------------------------------------------------------------------
Focus area Specific areas of interest
------------------------------------------------------------------------
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

70822 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices

judge, or perform a regulatory function previously participated in the ELP or research, manufacturing, academia, and
(e.g., compliance inspection), but rather, other FDA site visit programs. health care facilities. The focus areas
they are an opportunity to provide and specific areas of interest for visits
CDRH review staff a better II. CDRH ELP General Training
may include the following:
understanding of the products they Program
review. Through this notice, CDRH is A. Areas of Interest
formally requesting participation from
companies, academia, and clinical In this training program, groups of
facilities, including those that have CDRH staff will observe operations at

TABLE 1—AREAS OF INTEREST—OFFICE OF DEVICE EVALUATION
Focus area Specific areas of interest

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 po-
lymerized 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, overcoming common obstacles to starting and completing clinical trials, and inter-
medical devices. acting with various other stakeholders; preparing applications to request approval to conduct Investiga-
tional 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 vali-
dating cleaning, disinfection, or sterilization instructions; challenges in validating cleaning, disinfection, or
sterilization instructions; simulated use testing, particularly for validating sterilization methods and in-
structions; unique sterilization methods (e.g., use of flexible bags, mixed sterilants sound waves, ultra-
violet light, microwave radiation).

TABLE 2—AREAS OF INTEREST—OFFICE OF IN VITRO DIAGNOSTIC DEVICES AND RADIOLOGICAL HEALTH
Focus area Specific areas of interest

Manufacturing of in vitro diagnostic Pre-analytical devices (i.e., blood tubes), pathogen collection devices, micro collection/transport devices;
devices. general reagents, manual reagents; general assays, common point-of-care devices.
Instrument training of medical de- Hands-on instrument and system training; clinical implication of common laboratory testing; hands on famil-
vices (manufacturer or clinical iarization of medical imaging equipment in a hospital setting.
laboratory).
Quality system in manufacturing Observation of implemented quality systems practices based on current Good Manufacturing Practices; the
environments based on 21 CFR manufacturing of medical imaging or therapeutic radiology technologies.
part 820.

B. Site Selection seen in the Division of Dockets Dated: November 5, 2015.
CDRH will be responsible for CDRH Management (see ADDRESSES) between 9 Leslie Kux,
staff travel expenses associated with the a.m. and 4 p.m., Monday through Associate Commissioner for Policy.
site visits. CDRH will not provide funds Friday. [FR Doc. 2015–28857 Filed 11–13–15; 8:45 am]
to support the training provided by the The proposal should include a BILLING CODE 4164–01–P
site to this ELP General Training description of your facility relative to
Program. Selection of potential facilities focus areas described in tables 1 or 2.
will be based on CDRH’s priorities for Please include the Area of Interest (see DEPARTMENT OF HEALTH AND
staff training and resources available to tables 1 or 2) that the site visit will HUMAN SERVICES
fund this program. In addition to demonstrate to CDRH staff, a contact
person, site visit location(s), length of Food and Drug Administration
logistical and other resource factors, all
sites must have a successful compliance site visit, proposed dates, and maximum [Docket No. FDA–1977–N–0356 (Formerly
record with FDA or another Agency number of CDRH staff that can be 77N–0240); DESI 1786]
with which FDA has a memorandum of accommodated during a site visit.
Proposals submitted without this Drugs for Human Use; Drug Efficacy
understanding. If a site visit involves a
minimum information will not be Study Implementation; Nitroglycerin
visit to a separate physical location of
considered. In addition, please include Transdermal Systems; Withdrawal of
another firm under contract with the
an agenda outlining the proposed Hearing Request; Withdrawal of
site, that firm must agree to participate
training for the site visit. A sample Applications; Final Resolution of
in the ELP General Training program
request and agenda are available on the Hearing Requests Regarding
and must also have a satisfactory
Transdermal Systems Under Docket
tkelley on DSK3SPTVN1PROD with NOTICES

compliance history. ELP Web site at http://www.fda.gov/
downloads/ScienceResearch/ ACTION: Notice.
III. Request To Participate ScienceCareerOpportunities/
Submit proposals for participation UCM392988.pdf and http:// SUMMARY: The Food and Drug
with the docket number found in the www.fda.gov/scienceresearch/ Administration (FDA or Agency) is
brackets in the heading of this sciencecareeropportunities/ announcing that all outstanding hearing
document. Received requests may be ucm380676.htm. requests regarding nitroglycerin drug

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Document Created: 2015-12-14 14:12:42
Document Modified: 2015-12-14 14:12:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either an electronic or written request for participation in the ELP General Training Program by December 16, 2015.
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]
FR Citation		80 FR 70821

80 FR 70821 - Center for Devices and Radiological Health: Experiential Learning Program; General Training Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 220 (November 16, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration