EMERGO SUMMARY OF KEY POINTS:

• New US FDA guidance explains factors for determining if a microneedling product meets the definition of a medical device.
• Microneedling devices sold in the US typically lack predicate devices, making FDA classification of these products difficult.
• FDA encourages mirconeedling device manufacturers to pursue de novo registration if their devices are considered medical devices.

Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices.

In new draft guidance, FDA explains which types of microneedling products are considered medical devices (and thus fall under US regulatory oversight) and which do not according to intended use and related factors, as well as how the agency determines whether a microneedling product should be regulated as a device.

When is a microneedling device a medical device?

The FDA draft guidance notes the broad array of medical and cosmetic applications of microneedling products available for sale in the US, including skin exfoliation, scar and wrinkle treatment and treatment of acne and other skin conditions.

The intended use or “objective intent” of a microneedling product manufacturer largely determines if that product falls under FDA oversight as a device. Product claims a manufacturer makes related to the following applications likely fall under the definition of a medical device:

• Treatment of scars, wrinkles and/or cellulite and stretch marks
• Treatment of dermatoses, acne and/or hair loss
• Stimulation of collagen production or angiogenesis
• Supporting or promoting wound healing

FDA also considers design and technology characteristics of a microneedling product to determine if it meets the definition of a medical device, according to the guidance. Design and technology features the agency examines to make such determinations include needle length, arrangement and sharpness (do the needles penetrate living layers of skin?), as well as whether control of a microneedling product is primarily manual or mechanized.

Microneedling products not considered medical devices

On the other hand, microneedling products not intended by their manufacturers to treat, prevent or diagnose a disease or condition do not fall under FDA medical device oversight. Products whose primary applications include skin exfoliation, improved skin appearance, or provide a “luminous look” to skin as well as related products that do not penetrate living skin generally do not meet the definition of a medical device, according to the guidance.

Classification questions regarding microneedling devices

Due to the relative nascence of the microneedling product sector, no predicate medical devices currently exist necessary for substantial equivalence determinations regarding these products. Although such devices are typically considered Class III according to US law, FDA argues that de novo market authorization may be more appropriate for many types of microneedling devices.

De novo registration offers microneedling device manufacturers the chance to obtain lower-risk Class I or Class II classification; once registered as de novo devices, these product could also serve as predicate devices for future FDA registrants trying to commercialize similar products in the US.

Related US FDA resources from Emergo:

• US FDA consulting support for medical device and IVD companies
• FDA medical device classification consulting
• Whitepaper: Understanding the US FDA classification system
• Whitepaper: FDA regulations for novel and innovative devices