82_FR_43561 82 FR 43383 - Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

82 FR 43383 - Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

Page Range43383-43384
FR Document2017-19614

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Considerations for Microneedling Devices--Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 82 Issue 178 (Friday, September 15, 2017) 
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43383-43384]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19614]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4792]


Regulatory Considerations for Microneedling Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Regulatory 
Considerations for Microneedling Devices--Draft Guidance for Industry 
and Food and Drug Administration Staff.'' This draft guidance is being 
issued to assist industry in understanding when a microneedling product 
is a device as defined in the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act). This draft guidance is not final nor is it in effect at this 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DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-4792 for ``Regulatory Considerations for Microneedling 
Devices--Draft 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 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 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.thefederalregister.org/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 ``Regulatory Considerations for Microneedling Devices--Draft 
Guidance for Industry and Food and Drug Administration Staff'' 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 self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Peter Yang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1551, Silver Spring, MD 20993-0002, 301-796-6477.

SUPPLEMENTARY INFORMATION: 

I. Background

    ``Microneedling products'' is a generic term that encompasses 
instruments with common technological features that include an array of 
needles, ``micro-protrusion'' tips, or pins, which can be

[[Page 43384]]

blunt or sharp, and of varying lengths. This document discusses when 
microneedling products are devices as defined under section 201(h) of 
the FD&C Act (21 U.S.C. 321(h)). This draft guidance also provides 
clarity on the regulatory pathway to market for microneedling devices, 
resulting in more transparency and predictability to firms and 
stakeholders, which may translate into more efficient device 
development and patient access to such devices. The scope of this 
guidance document does not include microneedling combination products, 
acupuncture needles, hypodermic needles or other needles for injection, 
tattoo machine needles, and needle probes that emit any type of energy 
(e.g., radiofrequency needles) or deliver any type of energy to a 
patient (e.g., LASER, ultrasound).

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 this topic. 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 http://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 ``Regulatory 
Considerations for Microneedling Devices--Draft Guidance for Industry 
and Food and Drug Administration Staff'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1500036 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120, and the collections of information in 21 CFR 
part 801, regarding device labeling, have been approved under OMB 
control number 0910-0485.

    Dated: September 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19614 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43383 subject to review by the Office of including attachments, to https:// claimed confidential information Management and Budget (OMB) under www.regulations.gov will be posted to redacted/blacked out, will be available the Paperwork Reduction Act of 1995 the docket unchanged. Because your for public viewing and posted on (44 U.S.C. 3501–3520). The collections comment will be made public, you are https://www.regulations.gov. Submit of information in 21 CFR 516.119 solely responsible for ensuring that your both copies to the Dockets Management through 516.165 have been approved comment does not include any Staff. If you do not wish your name and under OMB control number 0910–0620. confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this IV. Electronic Access such as medical information, your or information on the cover sheet and not Persons with access to the internet anyone else’s Social Security number, or in the body of your comments and you may obtain the draft guidance at either confidential business information, such must identify this information as http://www.fda.gov/AnimalVeterinary/ as a manufacturing process. Please note ‘‘confidential.’’ Any information marked GuidanceComplianceEnforcement/ that if you include your name, contact as ‘‘confidential’’ will not be disclosed GuidanceforIndustry/default.htm or information, or other information that except in accordance with 21 CFR 10.20 https://www.regulations.gov. identifies you in the body of your and other applicable disclosure law. For Dated: September 11, 2017. comments, that information will be more information about FDA’s posting posted on https://www.regulations.gov. of comments to public dockets, see 80 Anna K. Abram, • If you want to submit a comment FR 56469, September 18, 2015, or access Deputy Commissioner for Policy, Planning, with confidential information that you Legislation, and Analysis. the information at: https://www.gpo.gov/ do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- [FR Doc. 2017–19609 Filed 9–14–17; 8:45 am] public, submit the comment as a 23389.pdf. BILLING CODE 4164–01–P written/paper submission and in the Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments DEPARTMENT OF HEALTH AND HUMAN SERVICES Written/Paper Submissions received, go to https:// www.regulations.gov and insert the Submit written/paper submissions as Food and Drug Administration docket number, found in brackets in the follows: heading of this document, into the [Docket No. FDA–2017–D–4792] • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets Regulatory Considerations for and/or go to the Dockets Management Management Staff (HFA–305), Food and Microneedling Devices; Draft Guidance Staff, 5630 Fishers Lane, Rm. 1061, Drug Administration, 5630 Fishers for Industry and Food and Drug Rockville, MD 20852. Lane, Rm. 1061, Rockville, MD 20852. Administration Staff; Availability • For written/paper comments You may submit comments on any submitted to the Dockets Management guidance at any time (see 21 CFR AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as 10.115(g)(5)). An electronic copy of the HHS. well as any attachments, except for guidance document is available for ACTION: Notice of availability. information submitted, marked and download from the internet. See the SUPPLEMENTARY INFORMATION section for identified, as confidential, if submitted SUMMARY: The Food and Drug information on electronic access to the as detailed in ‘‘Instructions.’’ Administration (FDA or Agency) is Instructions: All submissions received guidance. Submit written requests for a announcing the availability of the draft must include the Docket No. FDA– single hard copy of the draft guidance guidance entitled ‘‘Regulatory 2017–D–4792 for ‘‘Regulatory document entitled ‘‘Regulatory Considerations for Microneedling Considerations for Microneedling Considerations for Microneedling Devices—Draft Guidance for Industry Devices—Draft Guidance for Industry Devices—Draft Guidance for Industry and Food and Drug Administration and Food and Drug Administration and Food and Drug Administration Staff.’’ This draft guidance is being Staff.’’ Received comments will be Staff’’ to the Office of the Center issued to assist industry in placed in the docket and, except for Director, Guidance and Policy understanding when a microneedling those submitted as ‘‘Confidential Development, Center for Devices and product is a device as defined in the Submissions,’’ publicly viewable at Radiological Health, Food and Drug Federal Food, Drug, and Cosmetic Act https://www.regulations.gov or at the Administration, 10903 New Hampshire (the FD&C Act). This draft guidance is Dockets Management Staff between 9 Ave., Bldg. 66, Rm. 5431, Silver Spring, not final nor is it in effect at this time. a.m. and 4 p.m., Monday through MD 20993–0002. Send one self- DATES: Submit either electronic or Friday. addressed adhesive label to assist that written comments on the draft guidance • Confidential Submissions—To office in processing your request. by November 14, 2017 to ensure that the submit a comment with confidential FOR FURTHER INFORMATION CONTACT: Agency considers your comment on this information that you do not wish to be Peter Yang, Center for Devices and draft guidance before it begins work on made publicly available, submit your Radiological Health, Food and Drug the final version of the guidance. comments only as a written/paper Administration, 10903 New Hampshire ADDRESSES: You may submit comments submission. You should submit two Ave., Bldg. 66, Rm. 1551, Silver Spring, on any guidance at any time as follows: copies total. One copy will include the MD 20993–0002, 301–796–6477. information you claim to be confidential SUPPLEMENTARY INFORMATION: mstockstill on DSK30JT082PROD with NOTICES Electronic Submissions with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS I. Background following way: CONFIDENTIAL INFORMATION.’’ The ‘‘Microneedling products’’ is a generic • Federal eRulemaking Portal: Agency will review this copy, including term that encompasses instruments with https://www.regulations.gov. Follow the the claimed confidential information, in common technological features that instructions for submitting comments. its consideration of comments. The include an array of needles, ‘‘micro- Comments submitted electronically, second copy, which will have the protrusion’’ tips, or pins, which can be VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1

43384 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices blunt or sharp, and of varying lengths. of information in 21 CFR part 807, a version of the drug that was This document discusses when subpart E, regarding premarket previously approved. ANDA applicants microneedling products are devices as notification submissions, have been do not have to repeat the extensive defined under section 201(h) of the approved under OMB control number clinical testing otherwise necessary to FD&C Act (21 U.S.C. 321(h)). This draft 0910–0120, and the collections of gain approval of a new drug application guidance also provides clarity on the information in 21 CFR part 801, (NDA). regulatory pathway to market for regarding device labeling, have been The 1984 amendments include what microneedling devices, resulting in approved under OMB control number is now section 505(j)(7) of the Federal more transparency and predictability to 0910–0485. Food, Drug, and Cosmetic Act (21 U.S.C. firms and stakeholders, which may 355(j)(7)), which requires FDA to Dated: September 7, 2017. translate into more efficient device publish a list of all approved drugs. Anna K. Abram, development and patient access to such FDA publishes this list as part of the devices. The scope of this guidance Deputy Commissioner for Policy, Planning, ‘‘Approved Drug Products with Legislation, and Analysis. Therapeutic Equivalence Evaluations,’’ document does not include [FR Doc. 2017–19614 Filed 9–14–17; 8:45 am] which is known generally as the Orange microneedling combination products, acupuncture needles, hypodermic BILLING CODE 4164–01–P Book. Under FDA regulations, a drug is needles or other needles for injection, removed from the list if the Agency tattoo machine needles, and needle withdraws or suspends approval of the probes that emit any type of energy (e.g., DEPARTMENT OF HEALTH AND drug’s NDA or ANDA for reasons of radiofrequency needles) or deliver any HUMAN SERVICES safety or effectiveness or if FDA type of energy to a patient (e.g., LASER, determines that the listed drug was Food and Drug Administration ultrasound). withdrawn from sale for reasons of [Docket No. FDA–2017–P–1108] safety or effectiveness (21 CFR 314.162). II. Significance of Guidance A person may petition the Agency to This draft guidance is being issued Determination That TIMOPTIC (Timolol determine, or the Agency may consistent with FDA’s good guidance Maleate Ophthalmic Solution), 0.25 determine on its own initiative, whether practices regulation (21 CFR 10.115). Percent and 0.5 Percent, Was Not a listed drug was withdrawn from sale The draft guidance, when finalized, will Withdrawn From Sale for Reasons of for reasons of safety or effectiveness. represent the current thinking of FDA Safety or Effectiveness This determination may be made at any on this topic. It does not establish any time after the drug has been withdrawn AGENCY: Food and Drug Administration, rights for any person and is not binding from sale, but must be made prior to HHS. on FDA or the public. You can use an approving an ANDA that refers to the alternative approach if it satisfies the ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)). requirements of the applicable statutes SUMMARY: The Food and Drug FDA may not approve an ANDA that and regulations. This guidance is not Administration (FDA or Agency) has does not refer to a listed drug. subject to Executive Order 12866. determined that TIMOPTIC (timolol TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and III. Electronic Access maleate ophthalmic solution), 0.25 0.5 percent, is the subject of NDA percent and 0.5 percent, was not Persons interested in obtaining a copy 018086, held by Aton Pharma, Inc. and withdrawn from sale for reasons of of the draft guidance may do so by initially approved on August 17, 1978. safety or effectiveness. This downloading an electronic copy from TIMOPTIC is indicated for the treatment determination means that FDA will not the internet. A search capability for all of elevated intraocular pressure in begin procedures to withdraw approval Center for Devices and Radiological patients with ocular hypertension or of abbreviated new drug applications Health guidance documents is available open-angle glaucoma. (ANDAs) that refer to this drug product, TIMOPTIC (timolol maleate at http://www.fda.gov/MedicalDevices/ and it will allow FDA to continue to ophthalmic solution), 0.25 percent and DeviceRegulationandGuidance/ approve ANDAs that refer to the 0.5 percent, is currently listed in the GuidanceDocuments/default.htm. This product as long as they meet relevant ‘‘Discontinued Drug Product List’’ guidance document is also available at legal and regulatory requirements. section of the Orange Book. Orbicular https://www.regulations.gov. Persons unable to download an electronic copy FOR FURTHER INFORMATION CONTACT: Pharmaceutical Technologies, Pvt. Ltd., of ‘‘Regulatory Considerations for Robin Fastenau, Center for Drug submitted a citizen petition dated Microneedling Devices—Draft Guidance Evaluation and Research, Food and February 22, 2017 (Docket No. FDA– for Industry and Food and Drug Drug Administration, 10903 New 2017–P–1108), under 21 CFR 10.30, Administration Staff’’ may send an Hampshire Ave., Bldg. 51, Rm. 6236, requesting that the Agency determine email request to CDRH-Guidance@ Silver Spring, MD 20993–0002, 240– whether TIMOPTIC (timolol maleate fda.hhs.gov to receive an electronic 402–4510. ophthalmic solution), 0.25 percent and copy of the document. Please use the SUPPLEMENTARY INFORMATION: In 1984, 0.5 percent, was withdrawn from sale document number 1500036 to identify Congress enacted the Drug Price for reasons of safety or effectiveness. the guidance you are requesting. Competition and Patent Term After considering the citizen petition Restoration Act of 1984 (Pub. L. 98–417) and reviewing Agency records and IV. Paperwork Reduction Act of 1995 (the 1984 amendments), which based on the information we have at this This draft guidance refers to authorized the approval of duplicate time, FDA has determined under mstockstill on DSK30JT082PROD with NOTICES previously approved collections of versions of drug products under an § 314.161 that TIMOPTIC (timolol information found in FDA regulations. ANDA procedure. ANDA applicants maleate ophthalmic solution), 0.25 These collections of information are must, with certain exceptions, show that percent and 0.5 percent, was not subject to review by the Office of the drug for which they are seeking withdrawn for reasons of safety or Management and Budget (OMB) under approval contains the same active effectiveness. The petitioner has the Paperwork Reduction Act of 1995 ingredient in the same strength and identified no data or other information (44 U.S.C. 3501–3520). The collections dosage form as the listed drug, which is suggesting that this drug product was VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1


Document Created: 2017-09-15 00:18:28
Document Modified: 2017-09-15 00:18:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactPeter Yang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1551, Silver Spring, MD 20993-0002, 301-796-6477.
FR Citation82 FR 43383 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR