[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18850-18852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08017]


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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

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 the 2015 
Experiential Learning Program (ELP). 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 apply to participate in this formal training 
program for FDA's medical device review staff, or to contact CDRH for 
more information regarding the ELP.

DATES: Submit either an electronic or written request for participation 
in the ELP by May 8, 2015. The proposal should include a description of 
your facility relative to focus areas described in tables 1or 2). 
Please include the Area of Interest (see tables 1or 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.

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, <a href="/cdn-cgi/l/email-protection#6925081d060710084719061e0c0505290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="6c200d180302150d421c031b0900002c0a080d4204041f420b031a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH 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. 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 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 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, 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. ELP

A. ELP Training Component

    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--Medical Devices/Technology
------------------------------------------------------------------------
            Focus area                   Specific areas of interest
------------------------------------------------------------------------
Failure analysis of orthopedic      Methods for retrieval and
 devices.                            preservation of failed implants for
                                     analysis; understanding how
                                     retrieved implants may be analyzed;
                                     methods for identifying failure
                                     modes; understanding how analysis
                                     of failed implants influences
                                     device design modifications.
Radiologic analysis of orthopedic   Methods of radiologic analysis and
 devices.                            associated data analyses;
                                     radiologic imaging core
                                     laboratories.
Automated external defibrillators   Manufacturing process; incoming
 (AEDs).                             component inspection; design
                                     verification testing; human factors
                                     testing; returned product testing
                                     (as available).
Diagnostic imaging catheters for    Manufacturing process; design
 cardiovascular diseases.            verification testing; returned
                                     product testing (as available);
                                     ultrasound, optical coherence
                                     tomography (OCT), and near infrared
                                     spectroscopy (NIS) catheters.
Endovascular grafts for treatment   Physician-sponsored clinical
 of aortic aneurysms.                studies; observation of
                                     endovascular grafting surgical
                                     procedure; surgical planning
                                     process; factors that influence
                                     device modifications (e.g., patient
                                     anatomy, patient pathology).
Animal models for evaluation of     Models of traumatic injury and
 hemostatic devices.                 severe hemorrhage; limitations of
                                     the model; understanding the
                                     relevance of the data generated
                                     from these models in evaluating
                                     hemostatic devices.
Hyaluronic acid in dermal tissue    Manufacturing process; source
 fillers.                            materials; performance testing
                                     (e.g., material characterization,
                                     biocompatibility, residence time).
Minimally invasive glaucoma         Observation of a MIGS procedure;
 surgery (MIGS) devices.             surgical planning; surgical
                                     challenges.

[[Page 18851]]

 
Neurointerventional devices.......  Stents, flow-diverters, mesh balls,
                                     coils, and other related devices;
                                     observation of surgical procedures;
                                     understanding of clinical decision
                                     making for relevant patient
                                     populations; manufacturing;
                                     performance testing.
Implantable functional electrical   Observation of implantation
 stimulation devices.                procedure; surgical challenges.
Male condoms......................  Manufacturing process; lot release
                                     testing (e.g., airburst, water
                                     leak, dimensional analysis).
Solid organ preservation devices..  Observation of organ preservation
                                     procedures; pulsatile perfusion
                                     (for either cold storage or
                                     normothermia).
Infusion pumps....................  Manufacturing process; device design
                                     considerations; patch pumps;
                                     insulin pumps; implantable infusion
                                     pumps; implantable ports.
Bone grafting materials for dental  Manufacturing process; sourcing
 applications.                       process; viral inactivation
                                     testing; animal testing.
------------------------------------------------------------------------


Table 2--Areas of Interest--In Vitro Diagnostic and Radiological Devices/
                               Technology
------------------------------------------------------------------------
            Focus area                   Specific areas of interest
------------------------------------------------------------------------
Manufacturing of glucose test       Observation of the manufacturing and
 strips and meters.                  in-process and finished device
                                     testing of glucose monitoring
                                     devices.
Manufacturing of continuous         Observation of the manufacturing and
 glucose monitoring systems and      in-process and finished device
 insulin pumps.                      testing of glucose monitors and
                                     insulin pumps.
Manufacturing of chemistry devices  Observation of the manufacturing and
                                     in-process and finished device
                                     testing of point of care chemistry
                                     cassettes/cartridges/strips for
                                     smaller chemistry analyzers used in
                                     clinical and point of care
                                     settings.
Manufacturing of chemistry          Observation of the manufacturing and
 reagent, controls and calibrators.  in-process and finished device
                                     testing of chemistry reagents,
                                     calibrators, and controls for
                                     common chemistry analytes used in a
                                     clinical laboratory setting.
Manufacturing of urine test strips  Manufacturing and observation of in
 and readers.                        process or finished device testing
                                     for urine test strips and meters in
                                     clinical laboratory and point of
                                     care testing settings.
Manufacturing and development of    Observation of manufacturing, in-
 IHC (immunohistochemistry)          process testing, and/or finished
 devices.                            device testing of IHC devices (used
                                     in the diagnostic evaluation of
                                     cancer, classification of tumors,
                                     or companion diagnostic testing).
Manufacturing and development of    Observation of the manufacturing, in-
 ISH (in situ hybridization)         process testing, or finished device
 devices.                            testing of colorimetric in situ
                                     hybridization (CISH) and/or
                                     fluorescent in situ hybridization
                                     (FISH) assays used in identifying
                                     specific nucleic acid sequences
                                     within tissue sections (for
                                     diagnostic and/or treatment
                                     decisions).
Manufacturing and development of    Observation of NGS sequencing
 NGS (next gen sequencing)           platforms, bioinformatic analysis
 platforms and devices.              of the resulting sequence
                                     information, and types of
                                     interpretative software for
                                     potential clinical purposes.
Manufacturing, development and      Observation of the manufacturing, in-
 observation of CTC (circulating     process testing, or finished device
 tumor cells) devices.               testing of CTC devices that assess
                                     the prognosis of patients with
                                     metastatic breast, colorectal, or
                                     prostate cancer (manufacturing site
                                     or research site or clinical
                                     setting).
Manufacturing, development and/or   Observe the manufacturing,
 observation of clinical mass        development and/or demonstration of
 spectrometers and high              clinical mass spectrometers and
 performance liquid chromatography   HPLC as part of laboratory workflow
 (HPLC) devices.                     including sample preparation,
                                     equipment usage, and data analysis.
Manufacturing, development and      Manufacturing, research, and
 research of flow cytometry          development of in-process testing,
 devices and components.             or finished device testing of
                                     cytometry analyzers and
                                     accompanying components.
Manufacturing of immunoassays for   Manufacturing and development of in-
 autoimmune diseases.                process testing, or finished device
                                     testing, for diagnostic evaluation
                                     and research.
Manufacturing and development of    Manufacturing and development of in-
 coagulation--point of care          process or finished device testing
 devices.                            for point of care devices such as
                                     Prothrombin Time and International
                                     Normalized Ratio (PT/INR) meters.
Manufacturing and product           Manufacturing of global hemostasis
 development of global hemostasis    testing for anti-coagulants and
 testing devices.                    anti-platelet drugs for new
                                     molecular targets to assess the
                                     level of drug-induced inhibition
                                     for qualitative and quantitative
                                     evaluation.
Manufacturing and product           Manufacturing and development of
 development of direct               assays, controls, and calibrators
 anticoagulants assays/controls/     for the detection of direct
 calibrators.                        anticoagulants.
Observation of testing of           Visit a sequencing center where
 sequencing technologies in large    various sequencing methods are used
 sequencing centers.                 for different applications other
                                     than in vitro diagnostic devices
                                     (IVD) manufacturing.
Manufacturing, and product          Visit a manufacturer of IVD designed
 evaluation of IVDs using next       for sequencing of microorganisms
 generation sequencing (NGS)         for identification purposes.
 technology.
Clinical applications-NGS in        Visit a clinical laboratory that
 practice.                           uses NGS as a diagnostic/screening
                                     tool.
Antimicrobial susceptibility        Visit to a manufacturer of
 testing (AST).                      antimicrobial susceptibility test
                                     platforms intended for use in
                                     clinical laboratory settings.

[[Page 18852]]

 
Antimicrobial susceptibility        Visit to a clinical laboratory that
 testing (AST).                      employs various AST methodologies
                                     for identification of antibiotic
                                     resistance.
------------------------------------------------------------------------

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. 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 and must also have a satisfactory 
compliance history.

III. Request for Participation

    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.

    Dated: April 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08017 Filed 4-7-15; 8:45 am]
BILLING CODE 4164-01-P


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