[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]


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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'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