[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Pages 12737-12739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05387]



Food and Drug Administration

[Docket No. FDA-2015-N-0986]

Center for Devices and Radiological Health: Experiential Learning 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.


SUMMARY: The Food and Drug Administration's (FDA) Center for Devices 
and Radiological Health (CDRH or Center) is announcing the 2016 
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 request 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 April 11, 2016.

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 requests with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993-0002, 240-
402-2246, FAX: 301-827-3079, [email protected].


I. Background

    CDRH is responsible for helping to ensure 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

[[Page 12738]]

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 component 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 
    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.


A. Areas of Interest

    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--Office of Device Evaluation
               Focus area                   Specific areas of interest
Usability testing......................  Observe usability testing
                                          throughout a device's life
                                          cycle and complex clinical
Reprocessing and reuse of single-use     Observe reprocessing and reuse
 devices (SUDs).                          of SUDs in a major health
                                          system (i.e. Hospital
Transcatheter heart valves.............  Observe design, development,
                                          and testing of transcatheter
                                          heart valves, including
                                          pulmonic and aortic valve
                                          prostheses and related
Cardiac electrophysiology (EP)           Observe clinical EP catheter
 diagnostic, mapping, and ablation        laboratory and observe
 devices.                                 catheter ablation procedures
                                          (manual and potentially
                                          robotic); including EP Lab
                                          manager and practicing EP
Neurological medical devices--early      Design, development, and
 feasibility clinical trials.             testing of novel neurological
                                          medical devices qualified
                                          under early feasibility
                                          clinical trials.
Neurostimulators and neuroprosthetics    Design, development, and
 including brain-to-computer interface    testing of neurostimulators
 (BCI).                                   and neuroprosthetics including
                                          BCI technologies.
Non-clinical testing--animal model.....  Observe non-clinical animal
                                          model testing demonstrating
                                          the performance of bone void
                                          fillers in the posterolateral
Patient matched orthopaedic implants...  Observe the patient matched
                                          process from the surgeon's
                                          decision to utilize patient
                                          matched technology through
Auditory brainstem implants (ABI)......  Design, development, and
                                          testing of ABI and observe the
                                          surgical procedure and a post-
                                          implant programming session.
Contact lens care products.............  Design, development, and
                                          testing of contact lens care
                                          products and observe non-
                                          clinical testing for these
Surgical mesh devices..................  Design, development, and
                                          testing of surgical mesh
                                          indicated for gynecologic and
                                          urologic indications.
Feeding tubes..........................  Design, development, and
                                          testing of nasogastric tubes,
                                          nasojejunal tubes, and
                                          percutaneous endoscopic
                                          gastrostomy tubes.
Robotically-assisted surgical devices    Design, development, testing,
 (RASD) and surgical simulators in        and validation of emerging
 robotic surgery.                         RASD and mechanized
                                          laparoscopic technologies
                                          adopted from other specialties
                                          and new-area specific; and
                                          surgical simulators
                                          incorporating tissue models
                                          and force feedback mechanism
                                          or haptic technology to reduce
                                          learning curve in robotic
Biological evaluation (i.e.,             Observe all implanted, surface
 biocompatibility) and viral              contacting, and external
 inactivation of medical devices.         communicating devices.

     Table 2--Areas of Interest--Office of In Vitro Diagnostics and
                           Radiological Health
               Focus area                   Specific areas of interest
Continuous glucose monitoring systems    Design and development in-
 and insulin pumps.                       process, and finished device
                                          testing of continuous glucose
                                          monitoring systems and insulin
Urine test strips and readers..........  Design and development in-
                                          process, and finished device
                                          testing of urine test strips
                                          and readers.
Prothrombin (PT)/international           Design and development in-
 normalized ratio (INR) devices.          process, and finished device
                                          testing of PT/INR devices.
Direct anticoagulants (detection)......  Observe the detection of direct
Antimicrobial susceptibility testing     Observe clinical microbiology
 (phenotypic, biochemical, and            laboratory, contract research
 molecular detection).                    organization (CRO), and/or
                                          industrial setting where
                                          antimicrobial susceptibility
                                          testing is being applied.
Next generation sequencing (NGS).......  Observe clinical microbiology
                                          laboratory, CRO, and/or
                                          industrial setting where NGS
                                          is being applied.
Immunohistochemistry (IHC) reagents or   Design, development, and
 digital pathology devices.               testing of IHC reagents or
                                          digital pathology devices that
                                          are commonly used in pathology
Cell-free DNA/RNA biomarker technology.  Observe Clinical Laboratory
                                          Improvement Amendments labs
                                          involved with cfDNA, ctDNA, or
                                          miRNA for clinical
Radiological imaging equipment testing.  Observe radiological imaging
                                          equipment (e.g. CT, MR, PET,
                                          fluoroscopy, etc.) testing and
                                          evaluation of particular
                                          consensus standards.

[[Page 12739]]

Radiation therapy equipment............  Observe radiation therapy
                                          equipment (e.g., linear
                                          accelerator, proton beam
                                          therapy, brachytherapy)
                                          testing and evaluation.

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 the 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 To Participate

    Submit 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.
    The request should include a description of your facility relative 
to focus areas described in table 1 or 2. 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(s), length of site 
visit, proposed dates, and maximum number of CDRH staff that can be 
accommodated during a site visit. Requests submitted without this 
minimum information will not be considered.
    Additional information regarding the CDRH ELP, including a sample 
request and an example of the site visit agenda, is available on CDRH's 
Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05387 Filed 3-9-16; 8:45 am]