Description
Thisguidanceis 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.
Scope & Applicability
Product Classes
6Generic term for instruments with needle arrays
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Low risk medical devices
Device using needles to mechanically puncture and injure skin tissue
Devices for aesthetic use subject to special controls
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Technological characteristic affecting penetration depth
Identified Hazards
Hazards
4Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Risk to human health from failure to assure sterility
Risk mitigated by special controls
Risk mitigated by special controls
Related CFR Sections (6)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR878.4430§ 878.4430 Microneedling device for aesthetic use.
(a) Identification. A microneedling device for aesthetic use is 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 biologRead full regulation →
- 21CFR878.4800§ 878.4800 Manual surgical instrument for general use.
(a) Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brusRead full regulation →
- 21CFR878.4820§ 878.4820 Surgical instrument motors and accessories/attachments.
(a) Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments mayRead full regulation →
- 21CFR878.9§ 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →
Related Warning Letters (2)
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2021-06-29
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Aquavit Pharmaceuticals, Inc
See Also (8)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)
- Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff (Status: Final)
- Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Status: Final)
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry (Status: Final)
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (Status: Final)