[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24729-24731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09916]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0338]
Center for Devices and Radiological Health: Experiential Learning
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 an invitation for
participation in its Experiential Learning Program (ELP). The ELP
provides a formal training mechanism for regulatory review staff to
visit research, clinical, manufacturing, and health care facilities to
observe firsthand how medical devices are designed, developed, and
utilized. This training is intended to provide CDRH staff with an
opportunity to observe the device development life cycle and provide a
better understanding of the medical devices they review and the
challenges faced throughout development, testing, manufacturing, and
clinical use. The purpose of this document is to invite medical device
industry, academia, and health care facilities to participate in this
formal training program for FDA's medical device review staff, or to
contact CDRH for more information regarding the program.
DATES: Submit either an electronic or written request for participation
in this program by June 2, 2014. The request should include a
description of your facility relative to product areas regulated by
CDRH. Please include the Area of Interest (see table 1 or 2) that the
site visit will demonstrate to CDRH staff, a contact person, site visit
location, length of site visit, proposed dates, and maximum number of
CDRH staff that can be accommodated during a site visit. Submitted
proposals without this 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:
http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf
[[Page 24730]]
and http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.
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 comments 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 launched the ELP Pilot in 2012 and fully implemented the
program (78 FR 19711, April 2, 2013) in 2013. The Center 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 in the premarket review process. 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. This program is
a collaborative effort to enhance communication and facilitate the
premarket review process. Furthermore, CDRH is committed to
understanding current industry practices, innovative technologies, and
regulatory impacts and needs.
These formal training visits are not a mechanism for FDA to
inspect, assess, judge, or perform a regulatory function (i.e.,
compliance inspection), but rather, are an opportunity to provide the
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; other FDA site visit programs; and
new interested parties.
II. ELP
A. Experiential Learning Program
In this program, groups of CDRH staff will observe operations of
medical device establishments, including research, manufacturing,
academia, and health care facilities. The areas of focus and specific
areas of interest for visits may include the following:
Table 1--Areas of Interest--Medical Devices/Technology
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Focus area Specific areas of interest
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Advanced simulation testing of Performance testing of closed
mechanical ventilators. loop controlled ventilators
using advanced physiologic
simulation and computational
modeling of the system
(patient, ventilator, and
sensor).
Assisted reproductive technology (ART) Structure and organization of
clinic setting. an ART clinic; understanding
the necessary specifications
for ART devices (incubators,
microscopes, media,
micromanipulation, assisted
reproduction lasers, and lab
ware); cleaning and
disinfection of reprocessed
instruments in the ART clinic;
aseptic techniques used in ART
clinic.
Clinical use of orthopedic bone void Observation of surgical
filler devices. procedures (posterolateral
spine fusion, foot, ankle)
utilizing bone void fillers.
Clinical use of physical medicine Rehabilitation hospitals and
devices. programs; devices for
treatment of pain
(transcutaneous electrical
nerve stimulator, diathermy),
devices for muscle
rehabilitation (powered muscle
stimulators), devices intended
to help restore function to
patients (prosthetic limbs,
functional electrical
stimulators, orthoses).
Design and development of ablation Tumor ablation devices.
devices, including electrosurgical
units and accessories, electrosurgical/
ultrasonic devices, microwave ablation
devices.
Electrophysiology (EP) catheters for Observe manufacturing and
diagnostic (mapping) and therapeutic testing of EP devices, with
(ablation) indications. inclusion of design
verification and returned
product testing, as available.
Emerging manufacturing methods for 3D printing, rapid
orthopedic devices. manufacturing.
Endosseous implants.................... Computer Aided Design/Computer
Aided Manufacturers produced
elements, titanium bases, and
various software programs
utilized for forming
abutments.
Hemodialysis devices used in the home Home hemodialysis training
environment. program, hemodialysis
machines, ``wetness''
detectors, hemodialysis blood
access devices, water
treatment.
Interface between the brain thought Brain-computer interface
processes and the movement of medical manufacturer or laboratory.
devices to assist mobility.
Intraocular lenses (IOLs) and injectors Development and manufacture of
IOLs and injectors.
Manufacturing of polymeric sealants.... Vascular surgical sealants.
Refractive lasers...................... Manufacturing; preclinical
testing; femtosecond lasers.
Robotic surgery........................ Manufacturing of robotic
surgical devices.
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[[Page 24731]]
Table 2--Areas of Interest--In Vitro Diagnostic and Radiological Devices/
Technology
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Focus area Specific areas of interest
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Artificial pancreas related devices.... Manufacturing of continuous
glucose monitoring devices and
insulin pumps.
Manufacturing of different types of Manufacturing of antibodies
human antibodies for the use of (monoclonal and polyclonal)
immunoassays. for immunoassay tests.
Coagulation point of care and home use Coagulation devices for point
devices. of care and home use (COUMADIN
self-monitoring) utilizing
whole blood and/or citrated
plasma.
Immunohistochemistry for the diagnostic Immunohistochemistry as an
evaluation for cancer. important tool in biomarkers
detection and clinical
practice.
Systems capable of running multiple Systems maintaining quality
analytes composed of a specimen oversight of data generated at
collection and processing unit at a distant location and
satellite locations and data transmitted digitally to
transmittal to a central location for another location for analysis.
analysis and quality control oversight.
Antimicrobial resistance detection and Observation and hands-on
characterization. experience with reference
methods and assays for
phenotypic and non-phenotypic-
based methods for determining
antimicrobial resistance.
Diagnostic x-ray imaging devices....... Site visits to user facilities.
Next generation sequencing/single- Next generation sequencing and/
nucleotide polymorphism (SNP) arrays or SNP array devices in the
and clinical genomics. clinical laboratory setting
for molecular diagnostics
used.
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B. Site Selection
CDRH will be responsible for all CDRH staff travel expenses
associated with the site visits. CDRH cannot provide funds to support
the proposed training provided by the applicants to this 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 to the
applicant, that firm must agree to participate in the program and must
also have a satisfactory compliance history.
III. Request for Participation
Identify requests 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.
Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09916 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P