Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50135 

patient or unique to that patient’s 

treatment or diagnosis that has been 

recorded, stored, processed, retrieved, 

and/or derived from a legally marketed 

medical device. This information may 

include, but is not limited to, recorded 

patient data, device usage/output 

statistics, health care provider inputs, 

incidence of alarms, and/or records of 

device malfunctions or failures. 

FDA developed this guidance to 

convey FDA’s position regarding 

manufacturers appropriately and 

responsibly sharing patient-specific 

information with that patient at that 

patient’s request. In general, 

manufacturers may do so without 

undergoing additional premarket review 

in advance. FDA generally would not 

consider patient-specific information to 

be ‘‘labeling,’’ as defined in section 

201(m) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

321(m)). FDA is aware that when 

manufacturers share patient-specific 

information with patients, 

manufacturers also may provide them 

with supplemental information or other 

materials (e.g., descriptions of intended 

use, benefit and risk information, 

instructions for use) that may be 

considered labeling. Any labeling is 

subject to applicable requirements in 

the FD&C Act and FDA regulations. 

In the Federal Register of June 10, 

2016 (81 FR 37603), FDA announced the 

availability of the draft guidance 

formerly entitled ‘‘Dissemination of 

Patient-Specific Information from 

Devices by Device Manufacturers’’ and 

interested parties were invited to 

comment by August 9, 2016. FDA has 

considered all of the public comments 

received prior to finalizing this 

guidance. 

II. Significance of Guidance 

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 ‘‘Manufacturers 

Sharing Patient-Specific Information 

from Medical Devices with Patients 

Upon Request.’’ 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 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. 

Guidance documents are also available 

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

unable to download an electronic copy 

of ‘‘Manufacturers Sharing PatientSpecific Information from Medical 

Devices with Patients Upon Request’’ 

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

electronic copy of the document. Please 

use the document number 1500067 to 

identify the guidance you are 

requesting. 

Dated: October 24, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23517 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6069] 

Acceptance Review for De Novo 

Classification Requests; 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 ‘‘Acceptance Review 

for De Novo Classification Requests.’’ 

The purpose of this draft guidance is to 

explain the procedures and criteria FDA 

intends to use in assessing whether a 

request for an evaluation of automatic 

class III designation (De Novo 

classification request or De Novo 

request) meets a minimum threshold of 

acceptability and should be accepted for 

substantive review. This draft guidance 

discusses De Novo acceptance review 

policies and procedures, ‘‘Refuse to 

Accept’’ principles, and the elements of 

the De Novo Acceptance Checklist and 

the Recommended Content Checklist 

and is being issued to be responsive to 

an explicit deliverable identified in the 

Medical Device User Fee Amendments 

of 2017 (MDUFA IV). 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 29, 2017 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– 

2017–D–6069 for ‘‘Acceptance Review 

for De Novo Classification Requests; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES
50136 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

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 ‘‘Acceptance Review 

for De Novo Classification Requests’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or the Office of 

Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Sergio de del Castillo, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1538, 

Silver Spring, MD 20993–0002, 301– 

796–6419; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The automatic class III designation for 

devices of a new type occurs by 

operation of law and without any action 

by FDA, regardless of the level of risk 

posed by the device. Any device that is 

of a new type that was not in 

commercial distribution before May 28, 

1976, is automatically classified as, and 

remains within, class III and requires 

premarket approval unless and until 

FDA takes an action to classify or 

reclassify the device section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)). We refer to these devices as 

‘‘postamendments devices’’ because 

they were not in commercial 

distribution prior to the date of 

enactment of the Medical Device 

Amendments of 1976. 

FDA may classify a device through 

the De Novo classification process, 

which is the pathway authorized under 

section 513(f)(2) of the FD&C Act. A 

person may submit a De Novo request 

after submitting a premarket notification 

under section 510(k) of the FD&C Act 

(21 U.S.C. 360(k)) and receiving a not 

substantially equivalent (NSE) 

determination (section 513(f)(2)(A)(i) of 

the FD&C Act). A person may also 

submit a De Novo request without first 

submitting a premarket notification 

under section 510(k), if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence (section 513(f)(2)(A)(ii) of 

the FD&C Act). 

Upon receipt of a De Novo request, 

FDA is required to classify the device by 

written order (section 513(f)(2)(A)(iii) of 

the FD&C Act). The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. Per 

section 513(f)(2)(B)(i) of the FD&C Act, 

the classification is the initial 

classification of the device for the 

purposes of section 513(f)(1) of the 

FD&C Act. 

We believe De Novo classification 

enhances patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo classification process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (section 513(f)(2)(B)(i)). As a 

result, after a De Novo request is 

granted, other device sponsors do not 

have to submit a De Novo request or 

premarket application under section 515 

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

order to market a substantially 

equivalent device (see 21 U.S.C. 360c(i), 

defining ‘‘substantial equivalence’’). 

Instead, other device sponsors can use 

the less-burdensome 510(k) process, 

when applicable, as a pathway to 

market their device. 

FDA is issuing this draft guidance to 

provide clarity regarding the Agency’s 

expectations for information to be 

submitted in a De Novo request and 

ensure predictability and consistency 

for sponsors. Focusing the Agency’s 

review resources on complete De Novo 

requests will provide a more efficient 

approach to ensuring that safe and 

effective medical devices reach patients 

as quickly as possible. Moreover, with 

the enactment of MDUFA IV, FDA 

agreed to issuance of draft (and final) 

guidance which includes a submission 

checklist to facilitate a more efficient 

and timely review process to assist with 

new performance goals. Acceptance 

review therefore takes on additional 

importance in both encouraging quality 

applications from De Novo requesters 

and allowing the Agency to 

appropriately concentrate resources on 

complete applications. 

FDA anticipates that the Agency and 

industry may need a period of time to 

operationalize the policies within this 

guidance, when finalized. Therefore, if 

all criteria necessary to meet a 

minimum threshold of acceptability for 

De Novo requests as outlined in this 

guidance, when finalized, are not 

included in a De Novo request received 

by FDA before or up to 60 days after the 

publication of this guidance, when 

finalized, CDRH staff does not generally 

intend to refuse to accept. 

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 ‘‘Acceptance Review for De Novo 

Classification Requests.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50137 

it satisfies the requirements of the 

applicable statutes and regulations. This 

draft 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. 

Guidance documents are also available 

at https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Acceptance Review for De Novo 

Classification Requests’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 16055 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3502), 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, including each proposed 

revision of an existing 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. 

De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation) 

OMB Control Number 0910–0844— 

Revision 

To aid in the acceptance review, the 

guidance recommends that requesters 

complete and submit with their De 

Novo request an Acceptance Checklist 

that identifies the location of supporting 

information for each acceptance element 

and a Recommended Content Checklist 

that identifies the location of supporting 

information for each recommended 

content element. Therefore, we request 

revision of OMB control number 0910– 

0844, ‘‘De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation)’’ to include the Acceptance 

Checklist and the Recommended 

Content Checklist in the hourly burden 

estimate for De Novo requests. 

We previously estimated the average 

burden per response for a De Novo 

request under 21 U.S.C. 513(f)(2)(i) to be 

100 hours and under 21 U.S.C. 

513(f)(2)(ii) to be 180 hours. We 

estimate that it will take approximately 

1 hour to prepare an Acceptance 

Checklist and 1 hour to prepare a 

Recommended Content Checklist. Our 

estimate assumes that each De Novo 

request will include both checklists. 

Therefore, we estimate the revised 

average burden per response for a De 

Novo request under 21 U.S.C. 

513(f)(2)(i) to be 102 hours and under 21 

U.S.C. 513(f)(2)(ii) to be 182 hours. The 

revision results in a 104-hour increase 

in the total burden estimate. The 

average burden per response is based on 

estimates by FDA administrative and 

technical staff that are familiar with the 

requirements for submission of a De 

Novo request (and related materials), 

have consulted and advised 

manufacturers on submissions, and 

have reviewed the documentation 

submitted. 

Approved operating and maintenance 

costs for a De Novo request include 

printing, shipping, and eCopy costs. We 

believe any increase of the operating 

and maintenance cost resulting from the 

addition of the Acceptance Checklist 

and Recommended Content Checklist to 

be de minimis. Therefore, we are not 

requesting revision of the operating and 

maintenance cost estimate for OMB 

control number 0910–0844. 

Respondents to the information 

collection are medical device 

manufacturers seeking to market 

medical device products through 

submission of a De Novo classification 

request under section 513(f)(2) of the 

FD&C Act. 

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 

Total 

operating and 

maintenance 

costs 2

De Novo Request Under 21 U.S.C. 513(f)(2)(i) 

CDRH ..................................................... 25 1 25 102 2,550 ..........................

CBER ..................................................... 1 1 1 102 102 ..........................

De Novo Request Under 21 U.S.C. 513(f)(2)(ii) 

CDRH ..................................................... 25 1 25 182 4,550 ..........................

CBER ..................................................... 1 1 1 182 182 ..........................

Total De Novo requests .................. ........................ ........................ 52 ........................ 7,384 $6,308

Request for withdrawal2 ......................... 5 1 5 10 50 $5 


sradovich on DSK3GMQ082PROD with NOTICES
50138 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating and 

maintenance 

costs 2

Total ......................................... ........................ ........................ ........................ ........................ 7,434 $6,313 

1 There are no capital costs associated with this collection of information. 2 No change from approved information collection. This information is retained for the convenience of the reader. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23500 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–3275] 

Product Labeling for Certain Ultrasonic 

Surgical Aspirator Devices; 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 

guidance entitled ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices.’’ FDA is providing a specific 

labeling recommendation in this 

guidance to promote the safe and 

effective use of ultrasonic surgical 

aspirator devices. The labeling 

recommendation is being made in light 

of the risk of tissue dissemination and 

relates to use of these devices in the 

removal of uterine fibroids. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 30, 2017. 

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 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–3275 for ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

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 

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 

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 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 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 guidance 

document entitled ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices’’ 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 selfVerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

sradovich on DSK3GMQ082PROD with NOTICES