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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2021-D-0980]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability; extension of comment period.

# SUMMARY:

                        The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the                         **Federal Register**                         of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.                    

# DATES:

FDA is extending the comment period on the document published December 23, 2021 (86 FR 72969). Submit either electronic or written comments on the draft guidance by March 24, 2022, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-0980 for “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” 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 “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.                

# FOR FURTHER INFORMATION CONTACT:

Pras Pathmanathan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993-0002, 301-796-3490.

# SUPPLEMENTARY INFORMATION:

## I. Background

                    In the                     **Federal Register**                     of December 23, 2021, FDA published a notice of availability with a 60-day comment period to request comments on draft guidance for industry and FDA staff entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.”                

The Agency has received a request for an extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response.

                    FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until March 24, 2022. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly                           ( print page 4612)                        delaying guidance on these important issues.                

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 “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” 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 draft guidance document is also available at                     *https://www.regulations.gov*                     and at                     *https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents.*                     Persons unable to download an electronic copy of “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” may send an email request to                     *CDRH-Guidance@fda.hhs.gov*                     to receive an electronic copy of the document. Please use the document number 1500056 and complete title to identify the guidance you are requesting.                

Dated: January 25, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2022-01788 Filed 1-27-22; 8:45 am]

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