Contains Nonbinding Recommendations 
Regulatory Considerations for 
Microneedling Products
 
_____________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff
 
Document issued on November 10, 2020. 
The draft of this document was issued on September 15, 2017. 
For questions about this document, contact the OPEQ: Office of Product Evaluation and Quality, 
OHT4: Office of Surgical and Infection Control Devices, DHT4B: Division of Infection Control 
and Plastic and Reconstructive Surgery Devices, at (301) 796-6970. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
1  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov . Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2017-D-4792. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet.  You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 
1500036 to identify the guidance you are requesting. 
2 Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ............................................................................................................................. 4 
II.  Scope ....................................................................................................................................... 4 
III.  Definitions ............................................................................................................................... 6 
IV.  Microneedling Products That Are Devices ............................................................................. 6 
V.  Microneedling Products That Are Not Devices ...................................................................... 8 
VI.  Classification of Certain Microneedling Devices ................................................................... 9 
VII. Questions and Answers ........................................................................................................... 9 
3 Contains Nonbinding Recommendations 
Regulatory Considerations for 
Microneedling Products 
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) 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.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I.  Introduction 
This guidance is being issued to assist industry in understanding when a microneedling product 
is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (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. This document also provides information on the regulatory 
pathway to market for microneedling devices for aesthetic use. 
Throughout this guidance document, the term we refers to FDA staff from CDRH. You and 
your refers to the sponsor. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
II.  Scope 
This guidance addresses certain microneedling products, which 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. The 
needles1 are incorporated into the body of an instrument that facilitates rolling or stamping of 
                                                
1 For the purposes of this guidance document, the term needles refers to any configuration of needles, micro-
protrusion tips, or pins. 
4 Contains Nonbinding Recommendations 
these needles across or into the skin. For example, the needles may be attached to a cylinder that 
is rolled across the skin, attached perpendicular to a flat surface that is applied to the skin in a 
stamping fashion, or arranged in an array on the tip of a pen-shaped instrument. The 
application of needles to skin may be done manually, or motorized where the depth and speed of 
penetration of needles into the skin can be controlled. Other generic terms used to describe 
microneedling products include: microneedling or needling instruments, needlers, dermal rollers, 
microneedle rollers, microneedle stamps, dermal stamps, and variations thereof. 
Microneedling products have a wide range of uses from facilitating skin exfoliation and 
improvement of the appearance of skin, to treatment of scars, wrinkles, and other skin conditions 
(e.g., acne).  In addition, these products may be for single use or multiple use for a single or 
multiple users, and include, or have available separately, cleaning solutions, additional needle 
cartridges, and/or additional tips. 
Microneedling products have also been promoted with topically applied substances such as 
creams, ointments, gels, vitamin solutions, drugs, or blood products (e.g., platelet-rich plasma), 
which may be packaged together with the microneedling product or available separately where 
the microneedling product provides instructions for use with such topical products. Such 
microneedling products may be combination products under 21 CFR 3.2(e), which would be 
regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics 
Evaluation and Research (CBER), and/or the Center for Devices and Radiological Health 
(CDRH). Microneedling combination products are outside the scope of this guidance; 
manufacturers of such combination products should contact the Office of Combination Products 
(OCP) for additional information regarding the regulation of these products.2
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), and dermabrasion devices are also outside the 
scope of this guidance. 
Certain microneedling products are devices, whereas others are not. See sections IV and V for 
more information.  Sections VII.1 and VII.2 of this guidance provide examples of microneedling 
products that would be devices and that would not be devices, respectively.  
The guidance also covers the regulation of certain microneedling devices. Specifically, 
microneedling devices for aesthetic use are classified as class II devices under 21 CFR 878.4430.  
In addition, note that microneedling devices are different than dermabrasion devices, which are 
not within the scope of this guidance. Dermabrasion devices are classified as class I devices 
under 21 CFR 878.4800 (manual) and 21 CFR 878.4820 (motorized) and are exempt from the 
premarket notification (510(k)) process under section 510(k) of the FD&C Act, 21 U.S.C. 
                                                
2 For information on combination products, please refer to the Office of Combination Products webpage at 
https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-combination-products 
5 Contains Nonbinding Recommendations 
360(k), and 21 CFR part 807, subpart E, subject to the limitations in 21 CFR 878.9. According to 
CDRHs 1999 guidance document Guidance for Dermabrasion Devices,3 dermabrasion 
devices are defined as devices with indications for general dermabrasion, scar revision, acne 
scar revision, and tattoo removal. Dermabrasion devices utilize abrasion substrates such as 
brushes, rasps, and burrs that are intended to abrade or remove layers of the skin via shear forces. 
In contrast, microneedling devices utilize a substrate of needles. Although some dermabrasion 
devices and microneedling devices may have the same or similar intended uses, as identified 
above, microneedling devices have different technological characteristics and operate via 
different modes of action compared to dermabrasion devices which raise different questions of 
safety and effectiveness.  In addition, microneedling devices may have intended uses that are 
different from those of dermabrasion devices. 
III.  Definitions 
The following definitions are intended to be used within the context of this guidance and are not 
necessarily applicable to any context beyond this document. 
Stratum corneum: The stratum corneum is the superficial or outer layer of the epidermis, 
consisting of several layers of flat, keratinized, non-viable, peeling cells. The stratum corneum is 
a dead cell layer of skin, as opposed to living layers of skin. 
Exfoliation: Exfoliation is the detachment and shedding of superficial dead cells of the 
epidermis, i.e., the stratum corneum. 
Living layers of skin: Living layers of skin are layers of live cells and surrounding tissues (e.g., 
connective tissue) within the epidermis, dermis, and subcutis, including hair follicles and 
glandular structures. Living layers of skin exclude the stratum corneum. 
Dermabrasion: Dermabrasion is the abrading or eroding of skin via shear forces with abrasive 
substrates such as brushes, rasps, corundum, and burrs. 
IV.  Microneedling Products That Are Devices 
A.  Statutory Definition of a Device 
Under section 201(h) of the FD&C Act, a device is an instrument, apparatus, implement, 
machine, contrivance, implant, in vitro reagent, or other similar or related article, including any 
component, part, or accessory which is: 
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any 
supplement to them, 
                                                
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-dermabrasion-
devices-guidance-industry. 
6 Contains Nonbinding Recommendations 
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, 
treatment, or prevention of disease, in man or other animal, or 
(3) intended to affect the structure or any function of the body of man or other animal, and 
which does not achieve its primary intended purposes through chemical action within or 
on the body of man or other animals and which is not dependent upon being metabolized 
for the achievement of its primary intended purposes. 
Whether a microneedling product is a device depends, in part, on whether it is intended for use in 
the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of 
disease, or intended to affect the structure or any function of the body. A products intended use 
refers to the objective intent of those legally responsible for the labeling of a product,4 which is 
determined by their expressions or may be determined by considering the circumstances 
surrounding the distribution of a product.5 This objective intent may be shown, for example, by 
the claims made by a firm of a microneedling product, and from other relevant sources.   
B.  Determining Whether a Microneedling Product Is a 
Device 
FDA may consider the following, among other relevant sources, in determining whether a 
microneedling product is a device under the FD&C Act: 
1.  Firms Claims and Statements 
FDA may consider, among other things, any written or oral claims or statements in any 
label, labeling, advertising, and/or promotion of a microneedling product by or on behalf 
of a firm in determining whether a microneedling product is intended to cure, mitigate, 
treat or prevent disease or affect the structure or function of the body. Further, FDA 
considers claims or statements that indicate penetration or some effect beyond the stratum 
corneum into living layers of skin by such products to be evidence of a firms intent to 
affect the structure or function of the body. The stratum corneum is a dead layer of skin 
that is naturally shed through the desquamation process. Therefore, claims or statements 
regarding the removal of the stratum corneum are not considered an intent to affect the 
structure or function of the body.  In contrast, explicitly or implicitly claiming or stating 
that a microneedling product penetrates living layers of skin (e.g., epidermis and dermis) 
would be considered an intent to affect the structure or function of the body. The 
following are examples of claims or statements associated with microneedling products 
that FDA believes would generally cause the product to meet the device definition: 
  Treats scars (e.g., acne scars, atrophic scars, hypertrophic scars, burn scars) 
  Treats wrinkles and deep facial lines 
                                                
4 For the purposes of this guidance document, the term firm is used to refer to persons legally responsible for the 
labeling of devices under 21 CFR 801.4 as a convenience throughout the guidance. 
5 See 21 CFR 801.4. 
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  Treats cellulite and stretch marks 
  Treats dermatoses 
  Treats acne 
  Treats alopecia (hair loss) 
  Stimulates collagen production 
  Stimulates angiogenesis 
  Promotes wound healing 
2.  Product Design and Technological Characteristics/Features 
In addition to examining a firms claims and statements, FDA may consider the design 
and technological characteristics/features of a microneedling product in determining 
whether a microneedling product is a device under the FD&C Act. Specifically, FDA 
considers needle penetration beyond the stratum corneum as a result of the design or 
technology of a microneedling product as evidence that it may be intended to affect the 
structure or any function of the body under section 201(h) of FD&C Act. In considering 
the design and technological characteristics of these products, FDA may evaluate the 
following: 
  Needle length and arrangement and whether the specifications facilitate 
penetration into living layers of skin 
  Needle sharpness and whether that facilitates penetration into living layers of skin 
  Degree of control of manual or motorized microneedling products over the 
movement of needles and depth of penetration into living layers of skin 
Information regarding design and technological characteristics may be found in various 
places, including the products specifications, directions for use, or other materials.  
V.  Microneedling Products That Are Not Devices 
Microneedling products that are not intended for use in the diagnosis of disease or other 
conditions, or in the cure, mitigation, treatment or prevention of disease, and that are not 
intended to affect the structure or any function of the body, are not devices under section 201(h) 
of the FD&C Act. For example, generally, microneedling products that do not penetrate living 
skin (e.g., epidermal and dermal layers of the skin) and claim only to do the following would not 
be devices: 
  facilitate exfoliation of the skin (i.e., disruption or removal of the stratum corneum) 
  improve the appearance of skin 
  give skin a smoother look and feel 
  give skin a luminous look 
In general, such microneedling products would not be devices; however, the products may still 
be subject to other requirements of the FD&C Act or other Federal statutes or regulations 
administered by other Federal agencies. 
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VI.  Classification of Certain Microneedling Devices 
Microneedling devices for aesthetic use are classified as class II devices under 21 CFR 878.4430, 
subject to premarket notification (510(k)) and special controls outlined in the classification 
regulation (see 21 CFR 878.4430(b)(1)-(10)). Under 21 CFR 878.4430, a microneedling device 
for aesthetic use is identified as a device using one or more needles to mechanically puncture and 
injure skin tissue for aesthetic use. This classification does not include devices intended for 
transdermal delivery of topical products such as cosmetics, drugs, or biologics. FDA classified 
microneedling devices for aesthetic use into class II under section 513(f)(2) of the FD&C Act, 
also referred to as the De Novo classification process. This process provides a pathway to class I 
or class II classification for devices for which general controls or general and special controls 
provide a reasonable assurance of safety and effectiveness, but for which there is no legally 
marketed predicate device. Additional recommendations on information to include in a 510(k) 
submission for a microneedling device for aesthetic use is provided in response to Question 3 
below. 
VII.  Questions and Answers 
1. What are examples of microneedling products that would be 
devices? 
As discussed above, microneedling products are regulated as devices if they are intended to 
diagnose disease or other conditions, or cure, mitigate, treat, or prevent disease, or to affect 
the structure or function of the body, as defined under section 201(h) of the FD&C Act. The 
following are examples of microneedling products that FDA believes generally would be 
regulated as devices: 
a)  A manual microneedling product with short, blunt needles where the firm makes claims 
that the product is intended to exfoliate, give skin a luminous look, stimulate collagen 
production, and treat wrinkles 
In spite of the exfoliation and give skin a luminous look claims in this first example, the 
firm also makes claims that the microneedling product is intended to stimulate collagen 
production and treat wrinkles (i.e., affect the structure or function of skin); therefore, the 
product would be subject to FDA regulation as a device. 
b)  A motorized microneedling product with sharp needles that penetrate living layers of the 
skin, where the firm makes claims that the product is intended to make skin smoother by 
penetrating the skin to stimulate healing response and formation of new tissue 
This second example illustrates how FDA considers the design and technological 
characteristics of a microneedling product, in conjunction with claims by the firm, to 
determine whether the product is a device.  Here, the microneedling product is intended to 
affect the structure and function of the body.  Although making skin smoother may not 
necessarily require an effect on the structure or function of the body, such as through the 
9 Contains Nonbinding Recommendations 
removal or disruption of the stratum corneum, the firm makes claims that the product here is 
intended to penetrate living layers of the skin and designed the product to achieve this effect. 
Therefore, it would be subject to FDA regulation as a device.  
2. What are examples of microneedling products that would not 
be devices? 
As discussed above, microneedling products that are not intended to diagnose disease or 
other conditions, or cure, mitigate, treat or prevent disease and that are not intended to affect 
the structure or any function of the body are not devices, as defined under section 201(h) of 
FD&C Act. The following are examples of microneedling products that FDA believes 
generally would not be devices: 
a)  A microneedling product with short, blunt needles or micro-protrusion tips that do not 
penetrate living layers of skin and for which the firm claims that the product is intended 
to facilitate skin exfoliation 
b)  A microneedling product with short, densely packed needles that are not designed to 
penetrate living layers of skin and for which the firm claims that the product is intended 
to give skin a smoother look and feel 
In both examples, the products would not be devices. In these examples, the microneedling 
products are intended to be used to facilitate skin exfoliation and to give skin a smoother look 
and feel. Furthermore, the products are designed such that they would not penetrate living 
layers of skin due to the needle length, blunt needle tips, and/or densely packed needles. 
3. I have determined my microneedling product is a device 
regulated by CDRH. What are my next steps? 
Microneedling devices for aesthetic use were classified as class II devices under 21 CFR 
878.44306 as part of a De Novo classification request (DEN160029).7  
Manufacturers wishing to market their microneedling device for aesthetic use should submit 
a premarket notification (510(k))8 submission demonstrating substantial equivalence of their 
device to a legally marketed predicate microneedling device and compliance with the special 
controls as codified in 21 CFR 878.4430.  
                                                
6 Granting order available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160029.pdf and announced in 
the Federal Register on June 8, 2018 (83 FR 26575). 
7 DEN160029 Decision Summary is available at 
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160029.pdf. 
8 More information on the 510(k) review process is available in the FDA guidance document The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (the 510(k) program guidance), 
accessible at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k. 
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The special controls described in 21 CFR 878.4430(b)(1)-(10) mitigate the identified risks to 
health associated with microneedling devices for aesthetic use including adverse tissue 
reaction; cross-contamination and infection; electrical shock or electromagnetic interference 
with other devices; and damage to underlying tissue including nerves and blood vessels, 
scarring, and hyper/hypopigmentation due to exceeding safe penetration depth, mechanical 
failure, or software malfunction. 
The 510(k) submission should identify the predicate device to which the new microneedling 
device is compared. For a microneedling device that has new or modified indications for use 
and/or different technological characteristics when compared to the predicate device, FDA 
may request clinical performance data in addition to non-clinical testing if needed to make a 
substantial equivalence determination.9  For those submissions where clinical data is 
necessary to demonstrate substantial equivalence, we recommend considering the following 
when designing a clinical study: 
i)  The clinical study protocol should generally ensure that enrolled subjects are 
representative of the clinical population that the device is intended to treat. This 
should be reflected in the inclusion and exclusion criteria developed for the study. 
ii)  Safety data should generally be collected to support the safe use of the device. Such 
data should characterize the risks of infection, nerve and blood vessel damage, scar 
formation, hyper-/hypo-pigmentation, skin inflammation, allergic reactions, skin 
irritation, and other adverse events related to the use of the device. 
iii)  The proposed primary effectiveness endpoint should generally be developed to 
align with the proposed indications for use for your device. Effectiveness should be 
measured using a method that minimizes subjectivity or bias. FDA recommends use 
of validated measurement tools to assess device effectiveness. 
iv)  The follow-up period should ensure a reasonable assessment of the short-term and 
long-term performance of the device, as it relates to the safety and effectiveness 
endpoints as outlined above. 
As a resource for designing clinical studies, FDA recommends reviewing the guidance 
document Design Considerations for Pivotal Clinical Investigations for Medical Devices.10
If you have further questions regarding a proposed premarket submission, you may contact 
FDA via the Pre-Submission process. For more information regarding the Pre-Submission 
program, refer to the guidance document Requests for Feedback and Meetings for Medical 
Device Submissions: The Q-Submission Program.11
                                                
9 Please refer to the 510(k) program guidance discussed above for more information on the 510(k) review process. 
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-
pivotal-clinical-investigations-medical-devices. 
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program. 
11