46742 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

and rationales for withdrawing a 

standard. The guidance also provides 

that any interested party may request 

recognition of a standard. The draft 

guidance recommends that for 

recognition of a standard the request 

should, at a minimum, contain the 

following information: 

• Name and electronic or mailing 

address of the requestor; 

• Title of the standard; 

• Any reference number and date; 

• Proposed list of devices for which 

a declaration of conformity should 

routinely apply; 

• Basis for recognition, e.g., including 

the scientific, technical, regulatory, or 

other basis for such request; and 

• A brief identification of the testing 

or performance or other characteristics 

of the device(s) or process(es), that 

would be addressed by a declaration of 

conformity. 

Based on previous requests for 

recognition of standards, we estimate 

that FDA will receive nine requests 

annually. We estimate that each request 

will take less than 1 hour to prepare. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for recognition of a voluntary consensus standard 9 1 9 1 9 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

V. Reference 

The following reference is on display 

with the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. OMB, ‘‘Federal Participation in the 

Development and Use of Voluntary 

Consensus Standards and in Conformity 

Assessment Activities,’’ Circular A–119 

(revised). January 22, 2016. Available at: 

https://www.nist.gov/sites/default/files/ 

revised_circular_a-119_as_of_01-22- 

2016.pdf. 

Dated: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19993 Filed 9–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

510(k) Third-Party Review Program; 

Draft Guidance for Industry, Food and 

Drug Administration Staff, and ThirdParty Review Organizations; 

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 ‘‘510(k) Third-Party 

Review Program; Draft Guidance for 

Industry, Food and Drug Administration 

Staff, and Third-Party Review 

Organizations.’’ This draft guidance 

provides a comprehensive look into 

FDA’s current thinking regarding the 

510(k) Third-Party (3P) Review Program 

authorized under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

Under the FDA Reauthorization Act of 

2017 (FDARA), FDA was directed to 

issue draft guidance on the factors that 

will be used in determining whether a 

class I or class II device type, or subset 

of such device types, is eligible for 

review by an accredited person. The 3P 

Review Program is intended to allow 

review of devices by 3P Review 

Organizations to provide manufacturers 

of these devices an alternative review 

process that allows FDA to best utilize 

our resources on higher risk devices. 

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 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit either electronic or written 

comments on the collection of 

information by November 13, 2018. 

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– 

2016–D–2565 for ‘‘510(k) Third-Party 

Review Program.’’ 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. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46743 

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.gpo.gov/ 

fdsys/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. 

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 ‘‘510(k) Third-Party 

Review Program’’ to the Office of the 

Center Director, 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 selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Gregory Pishko, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5659, Silver Spring, 

MD 20993–0002, 240–402–6635. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s implementation of section 523 

of the FD&C Act (21 U.S.C. 360m) 

establishes a process for recognition of 

qualified third parties to conduct the 

initial review of premarket notification 

(510(k)) submissions for certain low-tomoderate risk devices eligible under the 

3P Review Program. Under FDARA 

(Pub. L. 115–52), the criteria used to 

establish device eligibility in the 3P 

Review Program changed and FDA was 

directed to issue draft guidance on the 

factors that will be used in determining 

whether a class I or class II device type, 

or subset of such device types, is 

eligible for review by an accredited 

person. The objectives of this draft 

guidance are: (1) To describe the factors 

FDA will use in determining device 

type eligibility for review by 3P Review 

Organizations; (2) to outline FDA’s 

process for the recognition, rerecognition, suspension, and 

withdrawal of recognition for 3P Review 

Organizations; and (3) to ensure 

consistent quality of work among 3P 

Review Organizations through Medical 

Device User Fee Amendments IV 

commitments authorized under FDARA. 

This draft guidance also outlines FDA’s 

current thinking on leveraging the 

International Medical Device Regulators 

Forum’s requirements for the Medical 

Device Single Audit Program. 

Upon issuance, this draft guidance 

will replace the draft guidance entitled 

‘‘510(k) Third-Party Review Program— 

Draft Guidance for Industry, Food and 

Drug Administration Staff, and ThirdParty Review Organizations’’ (81 FR 

62744) issued on September 12, 2016. 

This draft guidance, when finalized, 

will supersede ‘‘Implementation of 

Third-Party Programs Under the FDA 

Modernization Act of 1997; Final 

Guidance for Staff, Industry, and Third 

Parties’’ issued on February 2, 2001, and 

‘‘Guidance for Third Parties and FDA 

Staff; Third-Party Review of Premarket 

Notifications’’ issued on September 28, 

2004. 

II. Significance of Guidance 

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 the ‘‘510(k) Third-Party Review 

Program.’’ 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. This guidance is not 

subject to Executive Order 12866. 

III. 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/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘510(k) Third-Party Review Program’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 17–028 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

Under the PRA (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


daltland on DSKBBV9HB2PROD with NOTICES
46744 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

510(k) Third-Party Review Program 

(Formerly Medical Devices; Third-Party 

Review Under the Food and Drug 

Administration Modernization Act) 

OMB Control Number 0910–0375— 

Revision 

Information collections (ICs) 

associated with the 510(k) Third-Party 

Review Program have been approved 

under OMB control number 0910–0375, 

‘‘Medical Devices; Third-Party Review 

Under the Food and Drug 

Administration Modernization Act.’’ 

When finalized, the draft guidance 

entitled ‘‘510(k) Third-Party Review 

Program; Draft Guidance for Industry, 

Food and Drug Administration Staff, 

and Third-Party Review Organizations’’ 

will necessitate revisions to the burden 

estimates in OMB control number 0910– 

0375. 

Section 210 of the Food and Drug 

Administration Modernization Act 

(FDAMA) established section 523 of the 

FD&C Act (21 U.S.C. 360m), directing 

FDA to accredit persons in the private 

sector to review certain premarket 

notifications (510(k)s). Participation in 

this third-party review program by 

accredited persons is entirely voluntary. 

A third party wishing to participate will 

submit a request for accreditation to 

FDA. Accredited third-party reviewers 

have the ability to review a 

manufacturer’s 510(k) submission for 

selected devices. After reviewing a 

submission, the reviewer will forward a 

copy of the 510(k) submission, along 

with the reviewer’s documented review 

and recommendation, to FDA. Thirdparty reviewers should maintain records 

of their 510(k) reviews and a copy of the 

510(k) for a reasonable period of time, 

usually a period of 3 years. 

Respondents to this information 

collection are businesses or other forprofit organizations. 

FDA estimates the burden of this IC 

as follows: 

Estimated Annual Reporting Burden 

Requests for accreditation (initial): On 

average, the Agency has received one 

application for accreditation for 3P 

review per year. There is no change to 

this IC from the currently approved 

burden estimate. 

Requests for accreditation (rerecognition): We have added an IC for 

re-recognition requests to be consistent 

with the guidance which states that 

requests for re-recognition will be 

handled in the same manner as initial 

recognition requests. Based on the 

estimated number of 3P Review 

Organizations (7) and the frequency of 

re-recognition (3 years), we expect to 

receive approximately 2 re-recognition 

requests per year. We expect the average 

burden per response to be the same as 

an initial request (24 hours). 

510(k) reviews conducted by 

accredited third parties: Based on FDA’s 

recent experience with this program, we 

estimate the number of 510(k)s 

submitted for third-party review to be 

147 annually; approximately 21 annual 

reviews for each of the 7 3P Review 

Organizations. This IC has been 

adjusted based on current trends, 

however, there is no program change to 

this IC. 

Complaints: The guidance 

recommends that the 3P Review 

Organization should forward to FDA 

information on any complaint (e.g., 

whistleblowing) it receives about a 

510(k) submitter that could indicate an 

issue related to the safety or 

effectiveness of a medical device or a 

public health risk. Therefore, we have 

added an IC for complaints to the 

reporting burden. We expect to receive 

one forwarded complaint per year. 

Based on similar information 

collections, we estimate the average 

burden per complaint to be 0.25 hours 

(15 minutes). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Requests for accreditation (initial) 3 ..................................... 1 1 1 24 24 

Requests for accreditation (re-recognition) 5 ....................... 2 1 2 24 48 

510(k) reviews conducted by accredited third parties 4 ....... 7 21 147 40 5,880 

Complaints 5 ......................................................................... 1 1 1 0.25 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,952 

1There are no capital costs or operating and maintenance costs associated with this IC. 

(15 minutes) 

Estimated Annual Recordkeeping 

Burden 

510(k) Reviews: 3P Review 

Organizations should retain copies of all 

510(k) reviews and associated 

correspondence. Based on FDA’s recent 

experience with this program, we 

estimate the number of 510(k)s 

submitted for 3P review to be 147 

annually; approximately 21 annual 

reviews for each of the 7 3P Review 

Organizations. We estimate the average 

burden per recordkeeping to be 10 

hours. The estimated number of records 

and recordkeepers have been adjusted 

based on current trends, however, there 

is no program change to this IC. 

Records regarding qualifications to 

receive FDA recognition as a 3P Review 

Organization: Under section 704(f) of 

the FD&C Act (21 U.S.C. 374(f)), a 3P 

Review Organization must maintain 

records that support their initial and 

continuing qualifications to receive FDA 

recognition, including documentation of 

the training and qualifications of the 3P 

Review Organization and its personnel; 

the procedures used by the 3P Review 

Organization for handling confidential 

information; the compensation 

arrangements made by the 3P Review 

Organization; and the procedures used 

by the 3P Review Organization to 

identify and avoid conflicts of interest. 

Additionally, the draft guidance states 

that 3P Review Organizations should 

retain information on the identity and 

qualifications of all personnel who 

contributed to the technical review of 

each 510(k) submission and other 

relevant records. Therefore, we have 

added an IC for ‘‘Records regarding 

qualification to receive FDA recognition 

as a 3P Review Organization.’’ Because 

most of the burden of compiling the 

records is expressed in the reporting 

burden for requests for accreditation, we 

estimate the maintenance of such 

records to be 1 hour per recordkeeping 

annually. 

Recordkeeping system regarding 

complaints: Section 523(b)(3)(E)(iv) of 

the FD&C Act requires 3P Review 

Organizations to agree in writing that 

they will promptly respond and attempt 

to resolve complaints regarding their 

activities. The draft guidance 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46745 

recommends that 3P Review 

Organizations establish a recordkeeping 

system for tracking the submission of 

those complaints and how those 

complaints were resolved, or attempted 

to be resolved. Therefore, we have 

added an IC for ‘‘Recordkeeping system 

regarding complaints.’’ Based on our 

experience with the program and the 

recommendations in the guidance, we 

estimate the average burden per 

recordkeeping to be 2 hours. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

510(k) reviews 3 ................................................................... 7 21 147 10 1,470 

Records regarding qualifications to receive FDA recognition as a 3P Review Organization 4 ................................. 7 1 7 1 7 

Recordkeeping system regarding complaints 4 ................... 7 1 7 2 14 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,491 

1There are no capital costs or operating and maintenance costs associated with this IC. 

We revised our estimates for OMB 

control number 0910–0375 by adding 

new ICs, changing the title of the ICR, 

and adjusting the existing ICs based on 

current trends. Despite the addition of 

new ICs, the estimated burden reflects 

an overall decrease of 5,581 hours. We 

attribute this adjustment to a decrease in 

the number of submissions we received 

over the last few years. 

The draft guidance also refers to 

previously approved ICs found in FDA 

regulations. The ICs in 21 CFR part 807, 

subpart E have been approved under 

OMB control number 0910–0120; the 

ICs regarding 3P Review of medical 

devices under FDAMA have been 

approved under OMB control number 

0910–0375; the ICs for the device 

appeals processes have been approved 

under OMB control number 0910–0738; 

the ICs in the guidance document 

‘‘Requests for Feedback on Medical 

Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

have been approved under OMB control 

number 0910–0756. 

Dated: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19992 Filed 9–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

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 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 13, 2018 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– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ 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. 

• 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 


daltland on DSKBBV9HB2PROD with NOTICES