[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

[[Page 53484]]

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]
 BILLING CODE 4164-01-P


