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

• Citation: 85 FR 65409
• Published date: 15 October 2020
• Record Number: 2020-22877
• Section: Notices
• Court: Food And Drug Administration

65409

Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices

included in the Agency’s subsequent

request for OMB approval of the

proposed information collection. All

comments will become a matter of

public record.

Dated: October 8, 2020.

Marquita Cullom-Stott,

Associate Director.

[FR Doc. 2020–22795 Filed 10–14–20; 8:45 am]

BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2019–D–1261]

Technical Considerations for Non-

Clinical Assessment of Medical

Devices Containing Nitinol; 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 ‘‘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.

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.

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

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65410

Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices

the 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 guidance Topic OMB Control

No.

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231

814, subpart H ............................................................................ Humanitarian Device Exemption ............................................... 0910–0332

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078

‘‘De Novo Classification Process (Evaluation of Automatic

Class III Designation)‘‘. De Novo classification process .................................................. 0910–0844

‘‘FDA and Industry Procedures for Section 513(g) Requests for

Information under the Federal Food, Drug, and Cosmetic

Act‘‘.

513(g) Request for Information .................................................. 0910–0705

‘‘Requests for Feedback on Medical Device Submissions: The

Q-Submission Program and Meetings with Food and Drug

Administration Staff‘‘.

Q-submissions ........................................................................... 0910–0756

801 .............................................................................................. Medical Device Labeling Regulations ........................................ 0910–0485

820 .............................................................................................. Current Good Manufacturing Practice; Quality System Regula-

tion. 0910–0073

Dated: October 9, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for

Policy.

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

BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2013–D–0350]

Select Updates for Biocompatibility of

Certain Devices in Contact With Intact

Skin; Draft 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 the draft

guidance entitled ‘‘Select Updates for

Biocompatibility of Certain Devices in

Contact with Intact Skin.’’ FDA has

developed this draft guidance to

propose select updates to FDA’s current

thinking regarding the type of

biocompatibility information that

should be provided in a premarket

submission for certain devices made

from common polymers and fabrics that

are in contact with intact skin. 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 December 14, 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:

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

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jbell on DSKJLSW7X2PROD with NOTICES