Providing Regulatory Submissions for Medical Devices in Electronic Format-Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability, 42864-42867 [2020-15250]

Download as PDF 42864 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM. ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM is indicated in conjunction with cataract surgery for the reduction of intraocular pressure in adult patients with mild to moderate primary open angle glaucoma. Subsequent to this approval, the USPTO received patent term restoration applications for ISTENT INJECT TRABECULAR MICROBYPASS SYSTEM (U.S. Patent Nos. VerDate Sep<11>2014 19:37 Jul 14, 2020 Jkt 250001 7,867,186; 9,301,875; and 9,597,230) from Glaukos Corporation, and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated June 21, 2019, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ISTENT INJECT TRABECULAR MICROBYPASS SYSTEM is 2,508 days. Of this time, 2,330 days occurred during the testing phase of the regulatory review period, while 178 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: August 11, 2011. FDA has verified the applicant’s claim that the date the investigational device exemption for human tests to begin, as required under section 520(g) of the FD&C Act became effective, was August 11, 2011. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): December 26, 2017. The applicant claims December 21, 2017, as the date the premarket approval application (PMA) for ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM (PMA 170043) was initially submitted. However, FDA records indicate that PMA 170043 was submitted on December 26, 2017. 3. The date the application was approved: June 21, 2018. FDA has verified the applicant’s claim that PMA 170043 was approved on June 21, 2018. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,345 days, 496 days, or 1,783 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: July 10, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15295 Filed 7–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–3769] Providing Regulatory Submissions for Medical Devices in Electronic Format— Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.’’ Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain pre-submissions and submissions for devices be submitted in SUMMARY: E:\FR\FM\15JYN1.SGM 15JYN1 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not later than 1 year after the close of the public comment period, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates, and issuing a draft guidance on the topic. No later than 12 months after the close of the public comment period, the Agency will issue a final guidance. This guidance is intended to satisfy the final guidance documents referenced in the FDA&C Act and the MDUFA IV Commitment Letter. DATES: The announcement of the guidance is published in the Federal Register on July 15, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidance documents at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–3769 for ‘‘Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 42865 ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see § 10.115 (21 CFR 10.115(g)(5))). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Providing Regulatory Submissions for Medical Devices in Electronic Format— Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993–0002, 240–402–9677 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background Section 745A(b) of the FD&C Act (21 U.S.C. 379k–1(b)), amended by section 207 of FDARA (Pub. L. 115–52), requires that pre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act (21 U.S.C. 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3) or section 351 of the Public Health Service Act (42 U.S.C. 262) and any supplements to such pre-submissions or submissions, including appeals of those submissions, be submitted in electronic format specified by FDA beginning on such date as specified by FDA in final guidance. It also mandates that FDA issue a draft guidance not later than E:\FR\FM\15JYN1.SGM 15JYN1 42866 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the MDUFA IV Commitment Letter 1 from the Secretary of Health and Human Services to Congress, FDA committed to developing ‘‘electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process’’ and ‘‘by FY [fiscal year] 2020, the Agency will issue a draft guidance document on the use of the electronic submission templates.’’ No later than 12 months after the close of the public comment period, the Agency will issue a final guidance. This guidance is intended to satisfy the final guidance documents referenced in section 745A(b)(3) of the FD&C Act and the MDUFA IV Commitment Letter. The Agency has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by section 745A(b) of the FD&C Act in one guidance document. Accordingly, this guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3) of the FD&C Act, while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation. Specifically, this guidance discusses: (1) The submission types that must be submitted electronically, (2) criteria for waivers of and exemptions from the submissions in electronic format requirements, and (3) the timetable and process for implementing the requirements. A notice of availability for the draft guidance appeared in the Federal Register of November 25, 2019 (84 FR 50850). FDA considered the comments received and revised the guidance as appropriate in response to the comments, including an update to add real-time review Premarket approval application (PMA) supplements and a clarification that we intend to consider the time period necessary to transition to use of the electronic format when identifying the date on which electronic format will be required. In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the statutory requirement for electronic submissions solely in electronic format by providing standards, a timetable, and criteria for waivers and exemptions. To the extent that this document provides such requirements under section 745A(b)(3) of the FD&C Act (i.e., standards, timetable, criteria for waivers of and exemptions), indicated by the use of the mandatory words, such as must or required, this document is not subject to the usual restrictions in FDA’s good guidance practice regulations, such as the requirement that guidances not establish legally enforceable responsibilities. (See § 10.115(d).) However, this document also contains guidance on additional submission types for which submission in electronic format is not required. To the extent that this guidance describes recommendations that are not standards, timetable, criteria for waivers of, or exemptions under section 745A(b)(3), it is being issued in accordance with FDA’s good guidance practices regulation (§ 10.115). This guidance represents the Agency’s current thinking on this topic, and do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used for these recommendations if such an approach satisfies the requirements of the applicable statutes and regulations. This final guidance contains both binding and nonbinding provisions. II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance is also available at https:// www.regulations.gov or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Persons unable to download an electronic copy of ‘‘Providing Regulatory Submissions for Medical Devices in Electronic Format— Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19031 to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. 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. 3501–3521). The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. ‘‘FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act’’. ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’. 800, 801, and 809 ....................................................................... 820 .............................................................................................. Premarket Notification Submission ............................................ Premarket Approval Application ................................................ Humanitarian Use Device Exemption ........................................ Investigational Device Exemption .............................................. De Novo Classification Process ................................................ 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 513(g) Request for Information .................................................. 0910–0705 Pre-Submissions ........................................................................ 0910–0756 Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. 0910–0485 0910–0073 1 https://www.fda.gov/media/102699/download. VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices OMB control No. 21 CFR part or guidance Topic ‘‘Humanitarian Device Exemption Regulation: Q&As’’ ............... Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements. Emergency Use Authorization ................................................... Biologics License Applications ................................................... CLIA Waiver Applications .......................................................... 0910–0595 0910–0338 0910–0598 Administrative Procedures for CLIA Categorizations ................ 0910–0607 ‘‘Emergency Use Authorization of Medical Products’’ ................ 601 .............................................................................................. ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. ‘‘Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization’’. Dated: July 9, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15250 Filed 7–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1396] Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #265 entitled ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.’’ The draft guidance, if finalized, will describe FDA’s current thinking with respect to assisting sponsors in incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by October 13, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 42867 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2020–D–1396 for ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 0910–0661 made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42864-42867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3769]


Providing Regulatory Submissions for Medical Devices in 
Electronic Format--Submissions Under Section 745A(b) of the Federal 
Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Providing Regulatory 
Submissions for Medical Devices in Electronic Format--Submissions Under 
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' 
Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by 
the FDA Reauthorization Act of 2017 (FDARA) require that certain pre-
submissions and submissions for devices be submitted in

[[Page 42865]]

electronic format specified by FDA beginning on such date as specified 
in final guidance. It also mandates that FDA issue draft guidance not 
later than October 1, 2019, and a final guidance not later than 1 year 
after the close of the public comment period, providing for further 
standards for the submission by electronic format, a timetable for 
establishment of these further standards, and criteria for waivers of 
and exemptions from the requirements. In addition, in the Medical 
Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from 
the Secretary of Health and Human Services to Congress, FDA committed 
to developing electronic submission templates, and issuing a draft 
guidance on the topic. No later than 12 months after the close of the 
public comment period, the Agency will issue a final guidance. This 
guidance is intended to satisfy the final guidance documents referenced 
in the FDA&C Act and the MDUFA IV Commitment Letter.

DATES: The announcement of the guidance is published in the Federal 
Register on July 15, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidance documents at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-3769 for ``Providing Regulatory Submissions for Medical 
Devices in Electronic Format--Submissions Under Section 745A(b) of the 
Federal Food, Drug, and Cosmetic Act.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see Sec.  
10.115 (21 CFR 10.115(g)(5))).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Providing Regulatory Submissions for Medical Devices in Electronic 
Format--Submissions Under Section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act'' to the Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002, or to the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 240-
402-9677 or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), amended by 
section 207 of FDARA (Pub. L. 115-52), requires that pre-submissions 
and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 
515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act (21 U.S.C. 
360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 
360bbb-3) or section 351 of the Public Health Service Act (42 U.S.C. 
262) and any supplements to such pre-submissions or submissions, 
including appeals of those submissions, be submitted in electronic 
format specified by FDA beginning on such date as specified by FDA in 
final guidance. It also mandates that FDA issue a draft guidance not 
later than

[[Page 42866]]

October 1, 2019, providing for further standards for the submission by 
electronic format, a timetable for establishment of these further 
standards, and criteria for waivers of and exemptions from the 
requirements. In addition, in the MDUFA IV Commitment Letter \1\ from 
the Secretary of Health and Human Services to Congress, FDA committed 
to developing ``electronic submission templates that will serve as 
guided submission preparation tools for industry to improve submission 
consistency and enhance efficiency in the review process'' and ``by FY 
[fiscal year] 2020, the Agency will issue a draft guidance document on 
the use of the electronic submission templates.'' No later than 12 
months after the close of the public comment period, the Agency will 
issue a final guidance. This guidance is intended to satisfy the final 
guidance documents referenced in section 745A(b)(3) of the FD&C Act and 
the MDUFA IV Commitment Letter.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/media/102699/download.
---------------------------------------------------------------------------

    The Agency has concluded that it is not feasible to describe and 
implement the electronic format(s) that would apply to all the 
submissions covered by section 745A(b) of the FD&C Act in one guidance 
document. Accordingly, this guidance describes how FDA interprets and 
plans to implement the requirements of section 745A(b)(3) of the FD&C 
Act, while individual guidances will be developed to specify the 
formats for specific submissions and corresponding timetables for 
implementation. Specifically, this guidance discusses: (1) The 
submission types that must be submitted electronically, (2) criteria 
for waivers of and exemptions from the submissions in electronic format 
requirements, and (3) the timetable and process for implementing the 
requirements.
    A notice of availability for the draft guidance appeared in the 
Federal Register of November 25, 2019 (84 FR 50850). FDA considered the 
comments received and revised the guidance as appropriate in response 
to the comments, including an update to add real-time review Premarket 
approval application (PMA) supplements and a clarification that we 
intend to consider the time period necessary to transition to use of 
the electronic format when identifying the date on which electronic 
format will be required.
    In section 745A(b) of the FD&C Act, Congress granted explicit 
statutory authorization to FDA to specify in guidance the statutory 
requirement for electronic submissions solely in electronic format by 
providing standards, a timetable, and criteria for waivers and 
exemptions. To the extent that this document provides such requirements 
under section 745A(b)(3) of the FD&C Act (i.e., standards, timetable, 
criteria for waivers of and exemptions), indicated by the use of the 
mandatory words, such as must or required, this document is not subject 
to the usual restrictions in FDA's good guidance practice regulations, 
such as the requirement that guidances not establish legally 
enforceable responsibilities. (See Sec.  10.115(d).)
    However, this document also contains guidance on additional 
submission types for which submission in electronic format is not 
required. To the extent that this guidance describes recommendations 
that are not standards, timetable, criteria for waivers of, or 
exemptions under section 745A(b)(3), it is being issued in accordance 
with FDA's good guidance practices regulation (Sec.  10.115). This 
guidance represents the Agency's current thinking on this topic, and do 
not create or confer any rights for or on any person and do not operate 
to bind FDA or the public. An alternative approach may be used for 
these recommendations if such an approach satisfies the requirements of 
the applicable statutes and regulations. This final guidance contains 
both binding and nonbinding provisions.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance is also available at 
https://www.regulations.gov or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic copy of 
``Providing Regulatory Submissions for Medical Devices in Electronic 
Format--Submissions Under Section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 19031 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information in 
the following FDA regulations and guidances have been approved by OMB 
as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification        0910-0120
                                  Submission.
814, subparts A through E......  Premarket Approval            0910-0231
                                  Application.
814, subpart H.................  Humanitarian Use Device       0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
``FDA and Industry Procedures    513(g) Request for            0910-0705
 for Section 513(g) Requests      Information.
 for Information under the
 Federal Food, Drug, and
 Cosmetic Act''.
``Requests for Feedback on       Pre-Submissions........       0910-0756
 Medical Device Submissions:
 The Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.

[[Page 42867]]

 
``Humanitarian Device Exemption  Humanitarian Device           0910-0661
 Regulation: Q&As''.              Exemption Applications
                                  and Annual
                                  Distribution Number
                                  Reporting Requirements.
``Emergency Use Authorization    Emergency Use                 0910-0595
 of Medical Products''.           Authorization.
601............................  Biologics License             0910-0338
                                  Applications.
``Recommendations for Clinical   CLIA Waiver                   0910-0598
 Laboratory Improvement           Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
``Administrative Procedures for  Administrative                0910-0607
 Clinical Laboratory              Procedures for CLIA
 Improvement Amendments of 1988   Categorizations.
 Categorization''.
------------------------------------------------------------------------


    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15250 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P

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