[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19711-19713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07593]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (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
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 May 2, 2013. The request should include a
description of your facility relative to product areas CDRH regulates.
Please include the Area of Interest/Medical Device or Technology
(identified in table 1or 2) that the visit will demonstrate to CDRH
staff.
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 will fully implement the
program 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 safe, effective, high-quality 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 regulatory review staff and other staff involved in
the premarket review process. CDRH is driven to advance regulatory
science; provide industry with predictable, consistent, transparent,
and efficient regulatory pathways; and assure consumer
[[Page 19712]]
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. This request includes
those that have previously participated in the ELP or other FDA Site
Visit programs, as well as 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
------------------------------------------------------------------------
Focus area Specific areas of interest
------------------------------------------------------------------------
Performance validation and Ventilators, continuous positive
reliability testing of intensive airway pressure devices,
care unit ventilator and anesthesia anesthesia gas machines, and
gas machines. closed-loop ventilators.
Implantation techniques for spinal Implantation training and
devices. assessment using cadavers and
direct observation of surgical
procedures for spinal implants
including, but not limited to,
lateral intervertebral body
fusion devices, minimally
invasive pedicle screw systems,
and spinous process plates.
Manufacturing of ultra-high molecular All joint replacement devices.
weight polyethylene device
components.
Clinical use of orthopedic bone void Observation of surgical
filler devices. procedures (posterolateral spine
fusion, foot, ankle) utilizing
bone void fillers.
Reprocessing methods and techniques Cleaning and sterilization
in the clinical environment. methods and techniques for
endoscopes (including
colonoscopes, duodenoscopes,
cystoscopes, etc.) and
accessories; automatic endoscope
reprocessors.
Bariatric surgery.................... Observation of bariatric surgical
techniques, with and without
bariatric devices.
Manufacturing and assessment of Hemodialyzers, hemofilters,
hemodialyzers and filters. hemoconcentrators, ultrafilters,
and plasma filters.
Sourcing and manufacturing of animal- Surgical meshes, wound dressings.
derived collagen.
Traumatic wound care, management, and Observation of clinical uses of
treatment. wound management/treatment
devices and hemostatic products
for use on traumatic injuries.
Clinical use of plastic and Observation of surgical
reconstructive devices. procedures utilizing surgical
meshes, dermal fillers,
hemostatic agents, and bone
waxes.
Treatment of acute ischemic stroke... Clot retrieval procedures, clot
retrieval devices and ancillary
products (medications,
angiograms), stroke centers, and
acute stroke care programs.
Clinical use of neurosurgical Neuro-evoked response devices
monitoring devices. that are used for real-time
monitoring of patients
undergoing a back procedure.
Clinical use of rehabilitation Clinical use of physical medicine
devices. devices (prostheses, pressure-
relieving seat cushions, tilt-in-
space wheelchairs, and devices
for pain relief) in a
rehabilitation center setting
for treatment of various
conditions (e.g., spinal cord
injuries, traumatic brain
injuries, and amputations).
Clinical use of cardiovascular Endovascular stent grafts and
devices. associated delivery systems;
Stents and associated delivery
systems.
Manufacturing of cardiovascular Drug coated devices (e.g., stents
devices. and balloons), endovascular
stent grafts and associated
delivery systems, stents and
associated delivery systems,
percutaneous heart valves.
Animal testing for chronic care Observation of surgical
cardiovascular devices. procedures and chronic care
maintenance in animal models
using chronic care
cardiovascular devices, such as
heart valves and ventricular
assist devices.
Manufacturing of contact lenses and All contact lenses and care
care products. products.
Treatment of severe hearing loss..... Surgical implantation of cochlear
implants, electro-acoustic
stimulation using hybrid
cochlear implants, preservation
of residual hearing,
postoperative evaluation of
residual hearing and implant
performance.
Auditory brainstem implants (ABIs)... Observation of ABI surgical
procedures.
Management of clinical trials for Understanding clinical trial
medical devices. infrastructure, roles/
responsibilities of your
organization, and relationships
with other organizations
involved in the management and
conduct of clinical trials;
institutional review boards;
clinical research organizations.
------------------------------------------------------------------------
Table 2--Areas of Interest--In Vitro Diagnostic Devices/Technology
------------------------------------------------------------------------
Focus area Specific areas of interest
------------------------------------------------------------------------
Manufacturing and development of Molecular diagnostics devices,
molecular/immunology devices. and companion diagnostics
devices.
Manufacturing, development, and Semiautomated cytology screening
assessment of cytology/pathology devices; cytology collection
devices. devices use in human
papillomavirus tests;
immunohistochemistry tests
development in clinical trials.
Manufacturing of microbiology devices Antimicrobial susceptibility
devices.
[[Page 19713]]
Manufacturing of chemistry devices... Clinical Laboratory Improvement
Amendments (CLIA) waived
devices, blood collection tubes,
fecal occult blood devices.
Manufacturing and development of Hematology analyzers (specific
hematology devices. interest in new technology).
Manufacturing and development of Coagulation assays and controls,
coagulation devices. platelet aggregatometers
devices, prothrombin time/
international normalized ratio
meters and assays, D-Dimer
analyzers and assays.
Observation of clinical testing in a Observation of testing in a
CLIA high complexity laboratory. clinical testing environment.
------------------------------------------------------------------------
B. Site Selection
CDRH will be responsible for all travel expenses associated with
the site visits. Therefore, selection of potential facilities will be
based on the coordination of CDRH's priorities for staff training and
the resources available for 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 are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 28, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07593 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P