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

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