48430 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: August 17, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18586 Filed 8–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–D–0603 and FDA– 

2021–D–0604] 

Safety and Performance Based 

Pathway Device-Specific Guidances; 

Draft Guidances for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of two draft 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ and ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ The device-specific guidances 

identified in this notice were developed 

in accordance with the finalized 

guidance entitled ‘‘Safety and 

Performance Based Pathway.’’ These 

draft guidance documents are not final 

nor are they in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 29, 2021 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draft guidance before it begins work on 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–0603 for ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ and Docket 

No. FDA–2021–D–0604 for ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ Received comments will be 

placed in the dockets 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 ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ or ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff’’ 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: 

Jason Ryans, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 48431 

Ave., Bldg. 66, Rm. 1613, Silver Spring, 

MD 20993–0002, 301–796–4908. 

SUPPLEMENTARY INFORMATION: 

I. Background 

These draft device-specific guidance 

documents provide performance criteria 

for premarket notification (510(k)) 

submissions to support the optional 

Safety and Performance Based Pathway, 

as described in the guidance entitled 

‘‘Safety and Performance Based 

Pathway.’’ As described in that 

guidance, substantial equivalence is 

rooted in comparisons between new 

devices and predicate devices. However, 

the Federal Food, Drug, and Cosmetic 

Act does not preclude FDA from using 

performance criteria to facilitate this 

comparison. If a legally marketed device 

performs at certain levels relevant to its 

safety and effectiveness, and a new 

device meets those levels of 

performance for the same 

characteristics, FDA could find the new 

device as safe and effective as the 

legally marketed device. Instead of 

reviewing data from direct comparison 

testing between the two devices, FDA 

could support a finding of substantial 

equivalence with data demonstrating 

the new device meets the level of 

performance of an appropriate predicate 

device(s). Under this optional Safety 

and Performance Based Pathway, a 

submitter could satisfy the requirement 

to compare its device with a legally 

marketed device by, among other things, 

independently demonstrating that the 

device’s performance meets 

performance criteria as established in 

the above-listed guidance documents, 

when finalized, rather than using direct 

predicate comparison testing for some of 

the performance characteristics. 

These draft guidance documents are 

being issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidance 

documents, when finalized, will 

represent the current thinking of FDA 

on performance criteria for the Safety 

and Performance Based Pathway for 

‘‘Denture Base Resins’’ and ‘‘Facet 

Screw Systems.’’ They do not establish 

any rights for any person and are 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

at https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff (document 

number 20001)’’ or ‘‘Facet Screw 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Draft Guidance for Industry and Food 

and Drug Administration Staff 

(document number 21001)’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidance documents 

contain no new collection of 

information, they do 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 

regulation and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

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

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.Q-submissions; Pre-submissions ............. 0910–0756 

Dated: August 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18592 Filed 8–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Common Technical 

Document; Data Standards; 

Specifications for Electronic Common 

Technical Document Validation Criteria 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is announcing the date that FDA 

will begin rejecting submissions that fail 

either Electronic Common Technical 

Document (eCTD) validation 1551 or 

1553, which are high severity validation 

errors as described in the Specifications 

for eCTD Validation Criteria. Validation 

errors 1551 and 1553 have been added 

to the Specifications for eCTD 

Validation Criteria. 

DATES: Rejection for failing to pass 

either eCTD validation 1551 or 1553 

under a submission to CDER will begin 

on October 18, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Resnick, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3160, 

Silver Spring, MD 20993–0002, 301– 

796–7997, Jonathan.Resnick@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA’s 

CDER is issuing this Federal Register 

notice to announce that eCTD 

validations 1551 and 1553 have been 

added to the Specifications for eCTD 

Validation Criteria (available at https:// 

www.fda.gov/media/87056/download) 

as high validation errors. Beginning 

October 18, 2021, FDA will reject 

submissions that fail either of these 

validations. 

Under section 745A(a) (21 U.S.C. 

379k–1(a)) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), at least 

24 months after the issuance of a final 

guidance document in which FDA has 


khammond on DSKJM1Z7X2PROD with NOTICES