[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Pages 71656-71658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Regulatory Considerations for Microneedling Products; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Regulatory 
Considerations for Microneedling Products.'' This 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 
(FD&C Act). This document also provides information on the regulatory 
pathway to market for microneedling devices for aesthetic use.

DATES: The announcement of the guidance is published in the Federal 
Register on November 10, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-4792 for ``Regulatory Considerations for Microneedling 
Products.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

[[Page 71657]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Regulatory Considerations for Microneedling Products'' 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: Kimberly Ferlin, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4522, Silver Spring, MD 20993-0002, 240-
402-1834.

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 blunt or 
sharp, and of varying lengths. This document discusses when a 
microneedling product is a device as defined under section 201(h) of 
the FD&C Act (21 U.S.C. 321(h)), and is, therefore, subject to the 
device requirements under the FD&C Act and its implementing 
regulations.\1\ This guidance also provides clarity on the regulatory 
pathway to market for microneedling devices for aesthetic use, 
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, needle probes that emit any type of energy 
(e.g., radio-frequency needles) or deliver any type of energy to a 
patient (e.g., LASER, ultrasound), or dermabrasion devices. FDA 
considered comments received on the draft guidance that appeared in the 
Federal Register of September 15, 2017 (82 FR 43383). FDA revised the 
guidance as appropriate in response to the comments. Further, the 
guidance was revised to account for a De Novo request that was granted 
since issuance of the draft, which classified microneedling devices for 
aesthetic use into class II subject to premarket notification 
requirements under section 510(k) of the FD&C Act ((21 U.S.C. 360(k)) 
and special controls. The classification is codified at 21 CFR 
878.4430.
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    \1\ On September 23, 2020, FDA published a proposed rule to 
amend its intended use regulations for medical products (21 CFR 
201.128 and 801.4) to better reflect the Agency's current practices 
in evaluating whether a product is intended for use as a drug or 
device. As described in the proposed rule, FDA's longstanding 
position is that, in evaluating a product's intended use, any 
relevant source of evidence may be considered, including a variety 
of direct and circumstantial evidence. 85 FR 59718, 59721 (Sept. 23, 
2020).
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    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 ``Regulatory Considerations for 
Microneedling Products.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov and 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of 
``Regulatory Considerations for Microneedling Products'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1500036 to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
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 regulations and guidance have been 
approved by OMB as listed in the following table:

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                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.

[[Page 71658]]

 
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
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    Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24943 Filed 11-9-20; 8:45 am]
BILLING CODE 4164-01-P


