83 FR 53483 - Fostering Medical Innovation: Voluntary Pilot Program To Streamline Review of Premarket Notification (510(k)) Submissions for Ophthalmic Optical Coherence Tomography Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 205 (October 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 205 (October 23, 2018)
| Page Range | 53483-53485 | |
| FR Document | 2018-23059 |
[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)] [Notices] [Pages 53483-53485] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23059] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: Bradley.Cunningham@fda.hhs.gov. 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 bradley.cunningham@fda.hhs.gov. 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. [[Page 53485]] 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
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regarding whether the applicant for planning to achieve these goals through Therefore, there is a need for a better
extension acted with due diligence increased interactive engagement with understanding of premarket testing
during the regulatory review period. To manufacturers of OCT devices. FDA expectations for OCT devices and
meet its burden, the petition must intends to use the voluntary OCT 510(k) dialogue between FDA and OCT
comply with all the requirements of Pilot Program to assess whether the manufacturers in order to reduce the
§ 60.30, including but not limited to: individual testing recommendations need for additional data requests during
Must be timely (see DATES), must be provided through the pre-submission the 510(k) submission review.
filed in accordance with § 10.20, must process and increased interactive
engagement improve the premarket II. Description of the Voluntary OCT
contain sufficient facts to merit an FDA
review process and reduce the overall 510(k) Pilot Program
investigation, and must certify that a
true and complete copy of the petition total time to decision (TTD), a shared FDA intends to achieve the goals of
has been served upon the patent FDA-industry commitment goal, in the voluntary OCT 510(k) Pilot Program,
applicant. (See H. Rept. 857, part 1, 98th support of the Medical Device User Fee that are described in Section III, by: (1)
Cong., 2d sess., pp. 41–42, 1984.) Amendments of 2017. Communicating and obtaining feedback
Petitions should be in the format DATES: FDA is seeking participation in related to individual recommendations
specified in 21 CFR 10.30. the voluntary OCT 510(k) Pilot Program regarding non-clinical and clinical
Submit petitions electronically to beginning October 23, 2018. See the evaluation of OCT devices; and (2)
https://www.regulations.gov at Docket ‘‘Voluntary OCT 510(k) Pilot Program facilitating discussion between FDA and
No. FDA–2013–S–0610. Submit written Procedures’’ section for instructions on individual OCT device manufacturers
petitions (two copies are required) to the how to submit a request to participate. regarding these risk-based testing
Dockets Management Staff (HFA–305), The voluntary OCT 510(k) Pilot Program recommendations. Specifically,
Food and Drug Administration, 5630 will select the first nine eligible participants in the voluntary OCT
Fishers Lane, Rm. 1061, Rockville, MD participants. 510(k) Pilot Program will have the
20852. FOR FURTHER INFORMATION CONTACT: Brad
opportunity to discuss premarket
Dated: October 17, 2018. Cunningham, Center for Devices and performance testing recommendations
Leslie Kux, Radiological Health, Food and Drug for their OCT device in an interactive
Administration, 10903 New Hampshire format (by phone or in-person meeting)
Associate Commissioner for Policy.
Ave., Bldg. 66, Rm. 2430, Silver Spring, with the FDA review team, including
[FR Doc. 2018–23057 Filed 10–22–18; 8:45 am]
MD 20993, 301–796–6620, email: engineers, medical officers, and
BILLING CODE 4164–01–P managers. FDA will interactively
Bradley.Cunningham@fda.hhs.gov.
communicate and solicit feedback on its
SUPPLEMENTARY INFORMATION:
individual testing recommendations to
DEPARTMENT OF HEALTH AND I. Background yield a mutual, clear understanding of
HUMAN SERVICES the information necessary to
OCT devices are devices for viewing,
Food and Drug Administration imaging, measurement, and analysis of demonstrate substantial equivalence in
ocular structures and may be used to aid a 510(k) submission for the OCT device
[Docket No. FDA–2018–N–3623]
in the detection and management of and to streamline 510(k) submission and
various ocular diseases. These devices review.
Fostering Medical Innovation: Participation eligibility in this
Voluntary Pilot Program To Streamline are classified under 21 CFR 886.1570
and are assigned the product code OBO; voluntary OCT 510(k) Pilot Program is
Review of Premarket Notification determined based on the factors listed
(510(k)) Submissions for Ophthalmic they are Class II devices requiring
premarket notification (510(k)) prior to in Section IV. Due to resource
Optical Coherence Tomography constraints, we intend to limit this
Devices marketing. In their 510(k) submission,
for purposes of premarket clearance, voluntary pilot program to the first nine
AGENCY: Food and Drug Administration, manufacturers must demonstrate eligible participants.
HHS. substantial equivalence to a legally To evaluate success of the voluntary
ACTION: Notice. marketed predicate in terms of intended OCT 510(k) Pilot Program, we intend to
use, technological characteristics, and assess 510(k) TTD and feedback on the
SUMMARY: The Food and Drug performance. This is typically achieved pre-submission and 510(k) processes
Administration’s (FDA) Center for through evaluation of non-clinical and/ from participants in the pilot program.
Devices and Radiological Health, Office or clinical data, among other This voluntary pilot program is
of Device Evaluation recognizes that an information. limited to OCT devices, not already
efficient, risk-based approach to Currently, there are no FDA- cleared for marketing through 510(k),
regulating ophthalmic Optical recognized consensus standards or which could be classified under 21 CFR
Coherence Tomography (OCT) published guidance documents 886.1570.
technology will foster innovation available that describe performance III. Goals of the Voluntary OCT 510(k)
designed to improve ophthalmic testing recommendations for OCT Pilot Program
healthcare. To make premarket review devices. As such, 510(k) submissions,
of OCT devices more efficient, we are when initially submitted to FDA, often FDA has the following goals for the
announcing a new voluntary OCT do not include adequate testing to voluntary OCT 510(k) Pilot Program:
Premarket Notification (510(k)) Pilot support substantial equivalence. This is 1. Improve consistency and
khammond on DSK30JT082PROD with NOTICES
Program, designed to develop and refine evidenced by consistent requests for predictability of the 510(k) premarket
individual premarket testing additional information (including new review process for OCT devices.
recommendations for OCT devices data and analyses) across OCT 510(k) 2. Reduce TTD for OCT 510(k)
through the pre-submission process to submissions, which are unforeseen by submissions, noting that ‘‘FDA and
yield more consistent premarket manufacturers and may greatly applicants share the responsibility for
submissions and improve predictability contribute to an increase in TTD for an achieving this objective of reducing the
of the 510(k) review process. We are individual 510(k) submission. average Total Time to Decision, while
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maintaining standards for safety and the manufacturer is enrolled as a stated in this guidance, ‘‘[a]n acceptance
effectiveness’’ (Ref. 1). participant in the voluntary OCT 510(k) review will only begin for 510(k)
3. Increase collaboration between Pilot Program. Based on the intended submissions for which the appropriate
FDA and individual manufacturers to use and critical technological user fee has been paid and a validated
refine non-clinical and/or clinical characteristics of the OCT device and eCopy has been received.’’ As
testing recommendations. the proposed predicate device, provided recommended in the guidance, the
in the ‘‘statement of interest,’’ FDA also 510(k) should include a separate section
IV. Participation Eligibility intends to provide initial feedback with information on the pre-submission
Eligibility for participation in the regarding testing (non-clinical and/or under Section V.A., including the pre-
voluntary OCT 510(k) Pilot Program will clinical) recommendations for the
submission number, a copy of the FDA
be based on the following factors: specific OCT device.
3. If eligible and enrolled as a feedback (e.g., letter, meeting minutes),
1. Intent to submit a Traditional
510(k) for an OCT device, that could be participant, the OCT manufacturer and a statement of how or where in the
classified under 21 CFR 886.1570, should subsequently, yet in a timely 510(k) this prior feedback, including
within 1 year of acceptance to the manner (e.g., three months from each of the testing recommendations,
voluntary OCT 510(k) Pilot Program. notification of enrollment as a was addressed. Consistent with FDA’s
2. Commitment to support an participant), submit a pre-submission RTA policy as described in the
interactive review process and to that includes applicable information guidance, FDA intends to complete the
respond interactively and in a timely recommended in FDA’s Pre-submission acceptance review for the 510(k)
manner, as requested, during the 510(k) guidance (Ref. 2), including specific submission within 15 calendar days.
review, including response to any FDA questions for which the manufacturer is Once the OCT 510(k) has been
requests for additional information. seeking FDA input, along with the accepted for review, FDA intends to
3. Based on pre-submission proposed testing plan for its OCT complete review of the 510(k)
interactions, commitment to incorporate device, after considering FDA’s initial
submission within a TTD of 90 calendar
FDA feedback, including feedback, including recommendations,
days. To help achieve this, during the
recommendations provided on the provided in response to the ‘‘statement
of interest.’’ 510(k) review, FDA intends to resolve
testing plan, into the testing that will be any identified deficiencies through an
conducted to support the Traditional 4. During the pre-submission phase of
the pilot program, FDA intends to interactive process without placing the
510(k) submission.
provide feedback on the proposed OCT 510(k) submission on hold.
At its discretion, FDA may withdraw
a manufacturer from the OCT 510(k) testing plan and any specific questions Consistent with the participation
Pilot Program for not carrying out any included in the pre-submission within eligibility factors under Section IV, FDA
of the commitments mentioned 35 calendar days. In addition, and if expects manufacturers to provide timely
previously. requested by the manufacturer, FDA responses to FDA in response to
intends to schedule a meeting to occur deficiencies identified as part of an
V. Voluntary OCT 510(k) Pilot Program within one week after issuing feedback interactive review process. To facilitate
Procedures to the manufacturer during the pre- FDA-industry interaction, we will
A. Enrollment and Interaction for OCT submission phase to clarify or discuss provide a ‘‘point of contact’’ to ensure
Pre-submission alternative testing approaches. As a goal open, continual interaction during the
of the pilot program is to positively review process. Through the ‘‘point of
To be considered for the voluntary impact and reduce TTD for OCT 510(k)
OCT 510(k) Pilot Program, an OCT contact’’ person, the participants will be
submissions, FDA expects that the OCT able to communicate with the FDA
device manufacturer should submit a manufacturer will implement the testing
‘‘statement of interest’’ for participation review team (which intends to respond
plan, including any modifications to the
to bradley.cunningham@fda.hhs.gov. within two business days) to
plan based on feedback and dialogue,
The ‘‘statement of interest’’ should discussed during this pre-submission expeditiously address any issues related
include the following: (1) phase, during development of the 510(k) to the 510(k) submission. FDA will
Manufacturer’s name and contact submission. FDA welcomes feedback on evaluate the 510(k) consistent with
information; (2) explanation of why the our testing recommendations as part of existing 510(k) review processes and
manufacturer believes it meets the the voluntary OCT 510(k) Pilot Program. procedures, including those outlined in
participation eligibility factors outlined We recognize that manufacturers may FDA’s 510(k) Program Guidance (Ref. 4).
in Section IV; and (3) the intended use propose appropriate alternatives to FDA C. Assessment of the Voluntary OCT
(including indications for use) and recommendations, and we intend to
critical technological characteristics of 510(k) Pilot Program
provide feedback on any proposed
the OCT device for which a Traditional alternatives in the context of a pre- Following completion of the review of
510(k) will be submitted under the pilot submission submitted per Section V.A., 510(k)s in the voluntary OCT 510(k)
program as well as the proposed as part of the pilot program. Pilot Program, participating
predicate device. manufacturers will have the opportunity
The following captures the process for B. Refuse To Accept (RTA) and
Substantive 510(k) Review for OCT to provide individual feedback on the
the enrollment and pre-submission
510(k)s voluntary OCT 510(k) Pilot Program and
phase of the voluntary OCT 510(k) Pilot
Once the 510(k) for an OCT device its impact on consistency and
Program:
khammond on DSK30JT082PROD with NOTICES
1. Upon receiving a ‘‘statement of enrolled in the voluntary OCT 510(k) predictability of the 510(k) review
interest,’’ FDA will determine eligibility Pilot Program is received by FDA, it will process and FDA/manufacturer
based on the factors outlined in Section be screened to assess whether it meets collaboration during the pilot program.
IV. a minimum threshold of acceptability FDA intends to solicit feedback from
2. FDA intends to notify the for substantive review, as described in pilot program participants electronically
manufacturer via email whether the FDA’s guidance on its Refuse to Accept through an email questionnaire. TTD
manufacturer is eligible and/or whether (RTA) Policy for 510(k)s (Ref. 3). As will also be evaluated.
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VI. Duration of the OCT 510(k) Pilot GuidanceDocuments/UCM284443. comment will be made public, you are
Program Dated: October 17, 2018. solely responsible for ensuring that your
FDA intends to accept requests for Leslie Kux, comment does not include any
participation in the voluntary OCT Associate Commissioner for Policy.
confidential information that you or a
510(k) Pilot Program from the date of third party may not wish to be posted,
[FR Doc. 2018–23059 Filed 10–22–18; 8:45 am]
publication in the Federal Register such as medical information, your or
BILLING CODE 4164–01–P
through one year, or until the time when anyone else’s Social Security number, or
a total of nine participants have been confidential business information, such
enrolled. as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND
that if you include your name, contact
VII. Paperwork Reduction Act of 1995 HUMAN SERVICES
information, or other information that
This notice refers to previously Food and Drug Administration identifies you in the body of your
approved collections of information comments, that information will be
[Docket No. FDA–2014–N–1533] posted on https://www.regulations.gov.
found in FDA regulations and guidance.
These collections of information are • If you want to submit a comment
Agency Information Collection with confidential information that you
subject to review by the Office of Activities; Proposed Collection;
Management and Budget (OMB) under do not wish to be made available to the
Comment Request; National Panel of public, submit the comment as a
the Paperwork Reduction Act of 1995 Tobacco Consumer Studies
(44 U.S.C. 3501–3520). The collections written/paper submission and in the
of information in 21 CFR part 807, AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
subpart E have been approved under HHS. Submissions’’ and ‘‘Instructions’’).
OMB control number 0910–0120. The ACTION: Notice. Written/Paper Submissions
collections of information in ‘‘Requests Submit written/paper submissions as
for Feedback on Medical Device SUMMARY: The Food and Drug
Administration (FDA, Agency, or we) is follows:
Submissions: The Pre-Submission • Mail/Hand delivery/Courier (for
Program and Meetings with Food and announcing an opportunity for public
written/paper submissions): Dockets
Drug Administration Staff’’ have been comment on the proposed collection of
Management Staff (HFA–305), Food and
approved under OMB control number certain information by the Agency.
Drug Administration, 5630 Fishers
0910–0756. Under the Paperwork Reduction Act of
Lane, Rm. 1061, Rockville, MD 20852.
1995 (PRA), Federal Agencies are • For written/paper comments
VIII. References required to publish notice in the submitted to the Dockets Management
The following references are on Federal Register concerning each Staff, FDA will post your comment, as
display at the Dockets Management Staff proposed collection of information, well as any attachments, except for
(HFA–305), Food and Drug including each proposed extension of an information submitted, marked and
Administration, 5630 Fishers Lane, Rm. existing collection of information, and identified, as confidential, if submitted
1061, Rockville, MD 20852, and are to allow 60 days for public comment in as detailed in ‘‘Instructions.’’
available for viewing by interested response to the notice. This notice Instructions: All submissions received
persons between 9 a.m. and 4 p.m., solicits comments on the National Panel must include the Docket No. FDA–
Monday through Friday; they are also of Tobacco Consumer Studies. 2014–N–1533 for ‘‘Agency Information
available electronically at https:// DATES: Submit either electronic or Collection Activities; Proposed
www.regulations.gov. FDA has verified written comments on the collection of Collection; Comment Request; National
the website addresses, as of the date this information by December 24, 2018. Panel of Tobacco Consumer Studies.’’
document publishes in the Federal ADDRESSES: You may submit comments Received comments, those filed in a
Register, but websites are subject to as follows. Please note that late, timely manner (see ADDRESSES), will be
change over time. untimely filed comments will not be placed in the docket and, except for
1. MDUFA IV Commitment Letter, available considered. Electronic comments must those submitted as ‘‘Confidential
at https://www.fda.gov/downloads/ be submitted on or before December 24, Submissions,’’ publicly viewable at
ForIndustry/UserFees/ 2018. The https://www.regulations.gov https://www.regulations.gov or at the
MedicalDeviceUserFee/UCM535548.pdf.
2. FDA Guidance for Industry and FDA Staff
electronic filing system will accept Dockets Management Staff between 9
‘‘Requests for Feedback on Medical comments until 11:59 p.m. Eastern Time a.m. and 4 p.m., Monday through
Device Submissions: The Pre- at the end of December 24, 2018. Friday.
Submission Program and Meetings with Comments received by mail/hand • Confidential Submissions—To
Food and Drug Administration Staff’’ delivery/courier (for written/paper submit a comment with confidential
dated September 29, 2017, available at submissions) will be considered timely information that you do not wish to be
https://www.fda.gov/MedicalDevices/ if they are postmarked or the delivery made publicly available, submit your
DeviceRegulationandGuidance/ comments only as a written/paper
GuidanceDocuments/UCM311176.
service acceptance receipt is on or
3. FDA Guidance for Industry and FDA Staff before that date. submission. You should submit two
‘‘Refuse to Accept Policy for 510(k)s’’ copies total. One copy will include the
Electronic Submissions information you claim to be confidential
dated January 30, 2018, available at
https://www.fda.gov/MedicalDevices/ Submit electronic comments in the with a heading or cover note that states
DeviceRegulationandGuidance/ following way: ‘‘THIS DOCUMENT CONTAINS
khammond on DSK30JT082PROD with NOTICES
GuidanceDocuments/UCM315014. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
4. FDA Guidance for Industry and FDA Staff https://www.regulations.gov. Follow the Agency will review this copy, including
‘‘The 510(k) Program: Evaluating instructions for submitting comments. the claimed confidential information, in
Substantial Equivalence in Premarket
Notifications [510(k)]’’ dated July 28, Comments submitted electronically, its consideration of comments. The
2014, available at: https://www.fda.gov/ including attachments, to https:// second copy, which will have the
MedicalDevices/ www.regulations.gov will be posted to claimed confidential information
DeviceRegulationandGuidance/ the docket unchanged. Because your redacted/blacked out, will be available
VerDate Sep<11>2014 20:20 Oct 22, 2018 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1](https://thefederalregister.org/doc/83_FR_53688/page/3.svg)
Document Created: 2018-10-23 04:14:43
Document Modified: 2018-10-23 04:14:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 53483 |
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