On September 15, 2017, FDA published a draft guidance document titled “Regulatory Considerations for Microneedling Devices” (Draft Guidance). The Draft Guidance describes when a microneedling product is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and discusses the regulatory pathway for microneedling devices. Interested parties have 60 days, until November 14, to submit comments to FDA on the Draft Guidance.
The Draft Guidance defines “microneedling products” as encompassing “instruments with common technological features that include an array of needles, ‘micro-protrusion’ tips, or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 instrument can roll or stamp the needles across or into the skin. Other terms used to describe these products include needling instrument or dermal roller, among others. Microneedling products may have a range of intended uses, from skin exfoliation and improvement of skin appearance to treatment of scars, wrinkles, and other skin conditions.
Whether a microneedling product is a medical device depends, in part, on whether it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. In making that determination, FDA advises that it will review the claims for the product and the product’s design and technological characteristics.
Claims that indicate “penetration or some effect beyond the stratum corneum” (the outer layer of the epidermis, a dead cell layer of the skin) show an intent to affect the structure or function of the body. Device claims include: “Treats scars,” “Treats wrinkles and deep facial lines,” “Treats cellulite and stretch marks,” “Stimulates collagen production,” and “Promotes wound healing.” Claims that are not device claims include: “facilitate exfoliation of the skin,” “improvement in the appearance of skin,” “give skin a luminous look,” and “give skin a smoother look and feel.”
In addition to examining a firm’s claims, FDA will assess a product’s “design and technological characteristics/features” to determine intended use. FDA “considers needle penetration beyond the stratum corneum as a result of the design or technology” as evidence of intent to affect the structure or function of the body. In evaluating microneedle product design, FDA will consider needle length and arrangement, needle sharpness, and degree of control over the movement of needles and penetration depth, including whether each characteristic facilitates penetration into the living layers of the skin.
FDA explains that microneedling devices are distinct from dermabrasion devices in technological characteristics and mode of action. The Draft Guidance explains that dermabrasion devices use abrasion substrates (e.g., brushes and burrs) “to abrade and remove layers of the skin via shear forces.” In contrast, microneedling devices utilize needle penetration beyond the stratum corneum into living layers of the skin.
FDA also notes that microneedling devices have sometimes been promoted for use with topically applied substances, such as creams, ointments, drugs, or other products. These microneedling products may be combination products under 21 C.F.R. § 3.2(e), and are outside the scope of this Draft Guidance.
The Draft Guidance also advises that the appropriate regulatory pathway for microneedling devices is likely to be a de novo classification process, since there is no legally marketed predicate device on which to base a substantial equivalence determination. FDA would expect the de novo application to address risks such as infection, nerve and blood vessel damage, skin inflammation, allergic reactions, and other potential adverse events. The Draft Guidance provides a list of information and test data that may be needed, and states that clinical data may be necessary to address both short-term and long-term safety and effectiveness of microneedling devices.