Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 60838-60840 [2021-24061]

Download as PDF 60838 Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices 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 § 10.20 (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. 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: lotter on DSK11XQN23PROD with NOTICES1 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 or biologic 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 human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory VerDate Sep<11>2014 17:57 Nov 03, 2021 Jkt 256001 review period may count toward the actual amount of extension that the Director of USPTO may award (for example, 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 human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product, RECARBRIO. RECARBRIO is a combination of cilastatin, imipenem, and relebactam indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of the following infections caused by susceptible gram-negative bacteria: Complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections. Approval of these indications is based on limited clinical safety and efficacy data for RECARBRIO. Subsequent to this approval, the USPTO received a patent term restoration application for RECARBRIO (U.S. Patent No. 8,487,093) from Merck Sharp & Dohme Corp., and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated January 4, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of RECARBRIO represented the first permitted commercial marketing or use of relebactam, one of the three active ingredients in 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 RECARBRIO is 3,200 days. Of this time, 2,957 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 13, 2010. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 13, 2010. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: November 16, 2018. FDA has verified the applicant’s claim that the new drug application (NDA) for PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 RECARBRIO (NDA 212819) was initially submitted on November 16, 2018. 3. The date the application was approved: July 16, 2019. FDA has verified the applicant’s claim that NDA 212819 was approved on July 16, 2019. 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 application for patent extension, this applicant seeks 1,218 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may 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: October 28, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–24068 Filed 11–3–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0775] Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\04NON1.SGM 04NON1 Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices ACTION: Written/Paper Submissions Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Content of Premarket Submissions for Device Software Functions.’’ This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, this document will replace FDA’s ‘‘Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices’’ issued on May 11, 2005, and it will update FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by February 2, 2022 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: lotter on DSK11XQN23PROD with NOTICES1 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’’). VerDate Sep<11>2014 17:57 Nov 03, 2021 Jkt 256001 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– 2021–D–0775 for ‘‘Content of Premarket Submissions for Device Software Functions.’’ 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 60839 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)). 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 draft guidance document entitled ‘‘Content of Premarket Submissions for Device Software Functions’’ 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 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: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993–0002, 301–796–5528; 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 The purpose of this draft guidance is to describe FDA’s thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions. This thinking recognizes recent changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (Pub. L. 114–255), which amended section 520 of the FD&C Act (21 U.S.C. 360) and excludes certain software functions from the device definition. It also considers the rapidly evolving nature of digital health and recent FDArecognized consensus standards related to software. E:\FR\FM\04NON1.SGM 04NON1 60840 Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices This draft guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in this draft guidance also may help facilitate FDA’s premarket review. This draft guidance describes information that typically would be generated and documented during software development, verification, and design validation. The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses software. During premarket review, FDA may request additional information that is needed to evaluate the submission. When final, this document will replace FDA’s ‘‘Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices’’ issued on May 11, 2005, and it will update FDA’s thinking related to the documentation recommended for the review of device software functions in premarket submissions. biologics/guidance-complianceregulatory-information-biologics/ biologics-guidances. Persons unable to download an electronic copy of ‘‘Content of Premarket Submissions for Device Software Functions’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 337 and complete title to identify the guidance you are requesting. II. Electronic Access Persons interested in obtaining a copy of the draft 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 document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents or https://www.fda.gov/vaccines-blood- III. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table: 21 CFR part; guidance; or FDA form Topic 807, subpart E ................................. 814, subparts A through E .............. 814, subpart H ................................. 812 ................................................... ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. 800, 801, and 809 ........................... 820 ................................................... Premarket notification ........................................................................................................... Premarket approval ............................................................................................................... Humanitarian Device Exemption ........................................................................................... Investigational Device Exemption ......................................................................................... De Novo classification process ............................................................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Medical Device Labeling Regulations ................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .............. 0910–0485 0910–0073 Dated: October 29, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–24061 Filed 11–3–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1112] lotter on DSK11XQN23PROD with NOTICES1 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Content of Premarket Submissions for Device Software Functions.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer’s Certificate and Other Records Related to Participation in the National Shellfish Sanitation Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:57 Nov 03, 2021 Jkt 256001 The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Interstate Shellfish Dealer’s Certificate as well as the collection of other records related to participation in the National Shellfish Sanitation Program (NSSP). OMB control No. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: ADDRESSES: Submit either electronic or written comments on the collection of information by January 3, 2022. 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 DATES: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60838-60840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24061]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0775]


Content of Premarket Submissions for Device Software Functions; 
Draft Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 60839]]


ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Content of Premarket 
Submissions for Device Software Functions.'' This guidance document is 
intended to provide information regarding the recommended documentation 
sponsors should include in premarket submissions for FDA's evaluation 
of the safety and effectiveness of device software functions, which are 
functions that meet the definition of a device under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). When final, this document will 
replace FDA's ``Guidance for the Content of Premarket Submissions for 
Software Contained in Medical Devices'' issued on May 11, 2005, and it 
will update FDA's thinking related to the documentation FDA recommends 
sponsors include for the review of device software functions in 
premarket submissions. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 2, 2022 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:

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-2021-D-0775 for ``Content of Premarket Submissions for Device 
Software Functions.'' 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 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 draft guidance document entitled 
``Content of Premarket Submissions for Device Software Functions'' 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 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: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528; 
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

    The purpose of this draft guidance is to describe FDA's thinking on 
the recommended documentation sponsors should include in premarket 
submissions for FDA's evaluation of the safety and effectiveness of 
device software functions. This thinking recognizes recent changes to 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st 
Century Cures Act (Pub. L. 114-255), which amended section 520 of the 
FD&C Act (21 U.S.C. 360) and excludes certain software functions from 
the device definition. It also considers the rapidly evolving nature of 
digital health and recent FDA-recognized consensus standards related to 
software.

[[Page 60840]]

    This draft guidance identifies the software information generally 
necessary for evaluating the safety and effectiveness of a device in a 
premarket submission. The recommendations in this draft guidance also 
may help facilitate FDA's premarket review. This draft guidance 
describes information that typically would be generated and documented 
during software development, verification, and design validation. The 
least burdensome approach was applied to identify the minimum amount of 
information that, based on our experience, would generally be needed to 
support a premarket submission for a device that uses software. During 
premarket review, FDA may request additional information that is needed 
to evaluate the submission.
    When final, this document will replace FDA's ``Guidance for the 
Content of Premarket Submissions for Software Contained in Medical 
Devices'' issued on May 11, 2005, and it will update FDA's thinking 
related to the documentation recommended for the review of device 
software functions in premarket submissions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Content of 
Premarket Submissions for Device Software Functions.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft 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 document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download 
an electronic copy of ``Content of Premarket Submissions for Device 
Software Functions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 337 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations, guidance, and forms 
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
21 CFR part; guidance; or FDA                               OMB control
             form                        Topic                  No.
------------------------------------------------------------------------
807, subpart E...............  Premarket notification...       0910-0120
814, subparts A through E....  Premarket approval.......       0910-0231
814, subpart H...............  Humanitarian 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)''.
800, 801, and 809............  Medical Device Labeling         0910-0485
                                Regulations.
820..........................  Current Good                    0910-0073
                                Manufacturing Practice
                                (CGMP); Quality System
                                (QS) Regulation.
------------------------------------------------------------------------


    Dated: October 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24061 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P

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