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Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol; Guidance for Industry and Food and Drug Administration Staff; Availability

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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 “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” The Agency has developed this guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol due to the unique properties of nitinol. This guidance document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol.

DATES:

The announcement of the guidance is published in the Federal Register on October 15, 2020.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances 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-1261 for “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” 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 guidance document entitled “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol” 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. Send one self-addressed adhesive label to assist that office in processing your request.

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FOR FURTHER INFORMATION CONTACT:

Matthew Di Prima, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2124, Silver Spring, MD 20993-0002, 301-796-2507.

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SUPPLEMENTARY INFORMATION:

I. Background

The use of nitinol in medical devices began over three decades ago in product areas such as orthodontic archwires, cardiovascular guidewires, and surgical instruments. Its use has increased over the past two decades into different device areas such as orthopaedic fracture fixation, coronary stents, and transcatheter heart valves. With an increasing trend to treat patients using minimally invasive procedures, nitinol has become a popular choice of material due to its ability to return to its original shape after being mechanically deformed or after heat is applied. Given Start Printed Page 65410the complex thermomechanical behavior of nitinol, there are unique considerations when assessing the safety and performance of nitinol devices.

The Agency has developed this guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol. These recommendations are intended to be general and apply to medical devices that have at least one patient contacting component comprised of nitinol. The following technical areas are covered by this guidance: general information, mechanical testing, corrosion, biocompatibility, and labeling of nitinol devices.

A notice of availability of the draft guidance appeared in the Federal Register of April 19, 2019 (84 FR 16516). FDA considered comments received and revised the guidance as appropriate in response to the comments, including minor technical clarifications.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on technical considerations for non-clinical assessment of medical devices containing nitinol. 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 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. Persons unable to download an electronic copy of “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17013 and the complete guidance title 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 guidance have been approved by OMB as listed in the following table:

21 CFR part or guidanceTopicOMB Control No.
807, subpart EPremarket notification0910-0120
814, subparts A through EPremarket approval0910-0231
814, subpart HHumanitarian Device Exemption0910-0332
812Investigational Device Exemption0910-0078
“De Novo Classification Process (Evaluation of Automatic Class III Designation)“De Novo classification process0910-0844
“FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act“513(g) Request for Information0910-0705
“Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff“Q-submissions0910-0756
801Medical Device Labeling Regulations0910-0485
820Current Good Manufacturing Practice; Quality System Regulation0910-0073
Start Signature

Dated: October 9, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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[FR Doc. 2020-22877 Filed 10-14-20; 8:45 am]

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