[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53483-53485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23059]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3623]
Fostering Medical Innovation: Voluntary Pilot Program To
Streamline Review of Premarket Notification (510(k)) Submissions for
Ophthalmic Optical Coherence Tomography Devices
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, Office of Device Evaluation recognizes that an
efficient, risk-based approach to regulating ophthalmic Optical
Coherence Tomography (OCT) technology will foster innovation designed
to improve ophthalmic healthcare. To make premarket review of OCT
devices more efficient, we are announcing a new voluntary OCT Premarket
Notification (510(k)) Pilot Program, designed to develop and refine
individual premarket testing recommendations for OCT devices through
the pre-submission process to yield more consistent premarket
submissions and improve predictability of the 510(k) review process. We
are planning to achieve these goals through increased interactive
engagement with manufacturers of OCT devices. FDA intends to use the
voluntary OCT 510(k) Pilot Program to assess whether the individual
testing recommendations provided through the pre-submission process and
increased interactive engagement improve the premarket review process
and reduce the overall total time to decision (TTD), a shared FDA-
industry commitment goal, in support of the Medical Device User Fee
Amendments of 2017.
DATES: FDA is seeking participation in the voluntary OCT 510(k) Pilot
Program beginning October 23, 2018. See the ``Voluntary OCT 510(k)
Pilot Program Procedures'' section for instructions on how to submit a
request to participate. The voluntary OCT 510(k) Pilot Program will
select the first nine eligible participants.
FOR FURTHER INFORMATION CONTACT: Brad Cunningham, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2430, Silver Spring, MD 20993, 301-796-
6620, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
OCT devices are devices for viewing, imaging, measurement, and
analysis of ocular structures and may be used to aid in the detection
and management of various ocular diseases. These devices are classified
under 21 CFR 886.1570 and are assigned the product code OBO; they are
Class II devices requiring premarket notification (510(k)) prior to
marketing. In their 510(k) submission, for purposes of premarket
clearance, manufacturers must demonstrate substantial equivalence to a
legally marketed predicate in terms of intended use, technological
characteristics, and performance. This is typically achieved through
evaluation of non-clinical and/or clinical data, among other
information.
Currently, there are no FDA-recognized consensus standards or
published guidance documents available that describe performance
testing recommendations for OCT devices. As such, 510(k) submissions,
when initially submitted to FDA, often do not include adequate testing
to support substantial equivalence. This is evidenced by consistent
requests for additional information (including new data and analyses)
across OCT 510(k) submissions, which are unforeseen by manufacturers
and may greatly contribute to an increase in TTD for an individual
510(k) submission. Therefore, there is a need for a better
understanding of premarket testing expectations for OCT devices and
dialogue between FDA and OCT manufacturers in order to reduce the need
for additional data requests during the 510(k) submission review.
II. Description of the Voluntary OCT 510(k) Pilot Program
FDA intends to achieve the goals of the voluntary OCT 510(k) Pilot
Program, that are described in Section III, by: (1) Communicating and
obtaining feedback related to individual recommendations regarding non-
clinical and clinical evaluation of OCT devices; and (2) facilitating
discussion between FDA and individual OCT device manufacturers
regarding these risk-based testing recommendations. Specifically,
participants in the voluntary OCT 510(k) Pilot Program will have the
opportunity to discuss premarket performance testing recommendations
for their OCT device in an interactive format (by phone or in-person
meeting) with the FDA review team, including engineers, medical
officers, and managers. FDA will interactively communicate and solicit
feedback on its individual testing recommendations to yield a mutual,
clear understanding of the information necessary to demonstrate
substantial equivalence in a 510(k) submission for the OCT device and
to streamline 510(k) submission and review.
Participation eligibility in this voluntary OCT 510(k) Pilot
Program is determined based on the factors listed in Section IV. Due to
resource constraints, we intend to limit this voluntary pilot program
to the first nine eligible participants.
To evaluate success of the voluntary OCT 510(k) Pilot Program, we
intend to assess 510(k) TTD and feedback on the pre-submission and
510(k) processes from participants in the pilot program.
This voluntary pilot program is limited to OCT devices, not already
cleared for marketing through 510(k), which could be classified under
21 CFR 886.1570.
III. Goals of the Voluntary OCT 510(k) Pilot Program
FDA has the following goals for the voluntary OCT 510(k) Pilot
Program:
1. Improve consistency and predictability of the 510(k) premarket
review process for OCT devices.
2. Reduce TTD for OCT 510(k) submissions, noting that ``FDA and
applicants share the responsibility for achieving this objective of
reducing the average Total Time to Decision, while
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maintaining standards for safety and effectiveness'' (Ref. 1).
3. Increase collaboration between FDA and individual manufacturers
to refine non-clinical and/or clinical testing recommendations.
IV. Participation Eligibility
Eligibility for participation in the voluntary OCT 510(k) Pilot
Program will be based on the following factors:
1. Intent to submit a Traditional 510(k) for an OCT device, that
could be classified under 21 CFR 886.1570, within 1 year of acceptance
to the voluntary OCT 510(k) Pilot Program.
2. Commitment to support an interactive review process and to
respond interactively and in a timely manner, as requested, during the
510(k) review, including response to any FDA requests for additional
information.
3. Based on pre-submission interactions, commitment to incorporate
FDA feedback, including recommendations provided on the testing plan,
into the testing that will be conducted to support the Traditional
510(k) submission.
At its discretion, FDA may withdraw a manufacturer from the OCT
510(k) Pilot Program for not carrying out any of the commitments
mentioned previously.
V. Voluntary OCT 510(k) Pilot Program Procedures
A. Enrollment and Interaction for OCT Pre-submission
To be considered for the voluntary OCT 510(k) Pilot Program, an OCT
device manufacturer should submit a ``statement of interest'' for
participation to [email protected]. The ``statement of
interest'' should include the following: (1) Manufacturer's name and
contact information; (2) explanation of why the manufacturer believes
it meets the participation eligibility factors outlined in Section IV;
and (3) the intended use (including indications for use) and critical
technological characteristics of the OCT device for which a Traditional
510(k) will be submitted under the pilot program as well as the
proposed predicate device.
The following captures the process for the enrollment and pre-
submission phase of the voluntary OCT 510(k) Pilot Program:
1. Upon receiving a ``statement of interest,'' FDA will determine
eligibility based on the factors outlined in Section IV.
2. FDA intends to notify the manufacturer via email whether the
manufacturer is eligible and/or whether the manufacturer is enrolled as
a participant in the voluntary OCT 510(k) Pilot Program. Based on the
intended use and critical technological characteristics of the OCT
device and the proposed predicate device, provided in the ``statement
of interest,'' FDA also intends to provide initial feedback regarding
testing (non-clinical and/or clinical) recommendations for the specific
OCT device.
3. If eligible and enrolled as a participant, the OCT manufacturer
should subsequently, yet in a timely manner (e.g., three months from
notification of enrollment as a participant), submit a pre-submission
that includes applicable information recommended in FDA's Pre-
submission guidance (Ref. 2), including specific questions for which
the manufacturer is seeking FDA input, along with the proposed testing
plan for its OCT device, after considering FDA's initial feedback,
including recommendations, provided in response to the ``statement of
interest.''
4. During the pre-submission phase of the pilot program, FDA
intends to provide feedback on the proposed testing plan and any
specific questions included in the pre-submission within 35 calendar
days. In addition, and if requested by the manufacturer, FDA intends to
schedule a meeting to occur within one week after issuing feedback to
the manufacturer during the pre-submission phase to clarify or discuss
alternative testing approaches. As a goal of the pilot program is to
positively impact and reduce TTD for OCT 510(k) submissions, FDA
expects that the OCT manufacturer will implement the testing plan,
including any modifications to the plan based on feedback and dialogue,
discussed during this pre-submission phase, during development of the
510(k) submission. FDA welcomes feedback on our testing recommendations
as part of the voluntary OCT 510(k) Pilot Program. We recognize that
manufacturers may propose appropriate alternatives to FDA
recommendations, and we intend to provide feedback on any proposed
alternatives in the context of a pre-submission submitted per Section
V.A., as part of the pilot program.
B. Refuse To Accept (RTA) and Substantive 510(k) Review for OCT 510(k)s
Once the 510(k) for an OCT device enrolled in the voluntary OCT
510(k) Pilot Program is received by FDA, it will be screened to assess
whether it meets a minimum threshold of acceptability for substantive
review, as described in FDA's guidance on its Refuse to Accept (RTA)
Policy for 510(k)s (Ref. 3). As stated in this guidance, ``[a]n
acceptance review will only begin for 510(k) submissions for which the
appropriate user fee has been paid and a validated eCopy has been
received.'' As recommended in the guidance, the 510(k) should include a
separate section with information on the pre-submission under Section
V.A., including the pre-submission number, a copy of the FDA feedback
(e.g., letter, meeting minutes), and a statement of how or where in the
510(k) this prior feedback, including each of the testing
recommendations, was addressed. Consistent with FDA's RTA policy as
described in the guidance, FDA intends to complete the acceptance
review for the 510(k) submission within 15 calendar days.
Once the OCT 510(k) has been accepted for review, FDA intends to
complete review of the 510(k) submission within a TTD of 90 calendar
days. To help achieve this, during the 510(k) review, FDA intends to
resolve any identified deficiencies through an interactive process
without placing the OCT 510(k) submission on hold. Consistent with the
participation eligibility factors under Section IV, FDA expects
manufacturers to provide timely responses to FDA in response to
deficiencies identified as part of an interactive review process. To
facilitate FDA-industry interaction, we will provide a ``point of
contact'' to ensure open, continual interaction during the review
process. Through the ``point of contact'' person, the participants will
be able to communicate with the FDA review team (which intends to
respond within two business days) to expeditiously address any issues
related to the 510(k) submission. FDA will evaluate the 510(k)
consistent with existing 510(k) review processes and procedures,
including those outlined in FDA's 510(k) Program Guidance (Ref. 4).
C. Assessment of the Voluntary OCT 510(k) Pilot Program
Following completion of the review of 510(k)s in the voluntary OCT
510(k) Pilot Program, participating manufacturers will have the
opportunity to provide individual feedback on the voluntary OCT 510(k)
Pilot Program and its impact on consistency and predictability of the
510(k) review process and FDA/manufacturer collaboration during the
pilot program. FDA intends to solicit feedback from pilot program
participants electronically through an email questionnaire. TTD will
also be evaluated.
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VI. Duration of the OCT 510(k) Pilot Program
FDA intends to accept requests for participation in the voluntary
OCT 510(k) Pilot Program from the date of publication in the Federal
Register through one year, or until the time when a total of nine
participants have been enrolled.
VII. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120. The collections
of information in ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' have been approved under OMB control number
0910-0756.
VIII. References
The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. MDUFA IV Commitment Letter, available at https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
2. FDA Guidance for Industry and FDA Staff ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' dated September
29, 2017, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.
3. FDA Guidance for Industry and FDA Staff ``Refuse to Accept Policy
for 510(k)s'' dated January 30, 2018, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.
4. FDA Guidance for Industry and FDA Staff ``The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications
[510(k)]'' dated July 28, 2014, available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23059 Filed 10-22-18; 8:45 am]
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