[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12737-12739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05387]
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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 of availability.
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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].
SUPPLEMENTARY INFORMATION:
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
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. CDRH ELP
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
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Focus area Specific areas of interest
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Usability testing...................... Observe usability testing
throughout a device's life
cycle and complex clinical
simulations.
Reprocessing and reuse of single-use Observe reprocessing and reuse
devices (SUDs). of SUDs in a major health
system (i.e. Hospital
Reprocessor).
Transcatheter heart valves............. Observe design, development,
and testing of transcatheter
heart valves, including
pulmonic and aortic valve
prostheses and related
technology.
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
physicians.
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
spine.
Patient matched orthopaedic implants... Observe the patient matched
process from the surgeon's
decision to utilize patient
matched technology through
surgery.
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
devices.
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
surgery.
Biological evaluation (i.e., Observe all implanted, surface
biocompatibility) and viral contacting, and external
inactivation of medical devices. communicating devices.
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Table 2--Areas of Interest--Office of In Vitro Diagnostics and
Radiological Health
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Focus area Specific areas of interest
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Continuous glucose monitoring systems Design and development in-
and insulin pumps. process, and finished device
testing of continuous glucose
monitoring systems and insulin
pumps.
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
anticoagulants.
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
labs.
Cell-free DNA/RNA biomarker technology. Observe Clinical Laboratory
Improvement Amendments labs
involved with cfDNA, ctDNA, or
miRNA for clinical
diagnostics.
Radiological imaging equipment testing. Observe radiological imaging
equipment (e.g. CT, MR, PET,
fluoroscopy, etc.) testing and
evaluation of particular
consensus standards.
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Radiation therapy equipment............ Observe radiation therapy
equipment (e.g., linear
accelerator, proton beam
therapy, brachytherapy)
testing and evaluation.
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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]
BILLING CODE 4164-01-P