FDA Microneedling Regulations Status Update
Befuddled and Confused – Microneedling and the FDA
One of the most common questions received in our office is whether a product is “FDA Approved.” As microneedling grows in popularity this question is being asked about manual and motorized derma rollers as well. The question comes amid a confusing backdrop of events where Warning Letters and Import Actions cloud the already confusing regulatory landscape. Walking through the regulations step-by-step rather than jumping hastily to the approval question will clear-up the devices regulatory status.
It begins by understand the FDA mission. The FDA’s mandate at its broadest is to protect the public from physical and economic harm. This mission is carried out differently for domestic products and imported products. The simplest reason for this is that the US Constitution empowers executive agencies like the FDA with additional authority. This means at the US border the FDA’s power it at its ultimate peak. The result is a well-known regulatory truth – imported products need only “appear” to violate the Food Drug and Cosmetic Act (FD&C) to be refused or listed on an Import Alert. Domestic products on the other hand must be proven to violate the FD&C.
From this vantage point it becomes clear that not all FDA actions can be viewed equally. Import actions are subject to the “appear” standard which may not accurately reflect the regulatory status of a product.
When talking about point-of-view it is important to realize there are a number of places to find device information. Looking in the wrong spot, like Import Alerts, could lead to misguided conclusion. Device classification is rooted in the Code of Federal Regulations (CFR) and related Guidance Documents.
A recent Warning Letter to Derma Pen generated a great deal of attention. Many looking at the letter point to it as source material for device classification, but again it matters where you look. The FDA views Warning Letters as “informal” and merely serve as “recommendations.” Courts looking at Warning Letters find the letters cannot serve as the basis of a lawsuit because they are too informal and premature to represent a final opinion by the Agency. As exciting as the Derma Pen Warning Letter may be, like an Import Alert, it cannot and does not serve any role in device classification.
If we cannot look at enforcement actions, like Warning Letters and Import Alerts, then where is the “right” place to find a device classification?
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for all medical devices sold in the United States. The CDRH provides Guidance Documents and helps draft rules and regulations to interpret the FD&C. While there may be State regulation on the practice of medicine the FDA through the CDRH is the sole source of regulation on what constitutes a medical device. Therefore, the CDRH and the regulations (e.g. CFR) alone are the place to begin and extensively search for a device classification.
Once in the regulations the first question to ask is whether the product is a “medical device.” This is a broad term that captures hospital gowns to MRI machines. It is quite often a safe assumption that a therapeutic product is a device. From here medical device facilities fall under an obligation to review the regulations and identify an appropriate generic device type. Current FDA regulations establish classifications for approximately 1,700 different generic types of devices, which are grouped into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. This class sets the pre-market pathway – exempt (Class I), 510(k) (Class II) or PMA (Class III).
Device classification depends on the intended use of the device and also upon indications for use. The two concepts are easy to confuse. In essence one is asking, “What does the device do” and the other “What does it treat?” The majority of the microneedling industry registers and lists microneedling devices under regulation 21 CFR 878.4820 (product code GFE). This is a Class I 510(k) exempt classification with an intended use for general dermabrasion and indications for use of scar revision, acne scar revision, and tattoo removal. The intended use and indications for use provide a reasonable basis to use the device classification.
A “reasonable basis” sounds a little legalese, but the FDA is not seeking a perfect match. The regulations are written to encompass a wide range of facilities types, device types, and evolving technology. Regulations are therefore by nature intentionally ambiguous. The FDA itself struggles with classification. My derma roller clients have had some products deemed devices by one district and cosmetics by another, for example. A firm introducing a device simply must act in good faith and diligently document how a device category is a reasonable fit.
We have to remember the FDA is a federal agency constrained by an annual budget. It lacks the personnel and resources to provide an opinion or approval letter for every product it regulates. From the cheese and bread to the mascara and face creams we daily use FDA regulated products that cannot produce an FDA approval letter. The same is true for the thousands of Class I devices on the market . Those devices are deemed low-risk and not a good use of limited FDA resources to review and approve. Thus, no manufacturer or seller of any Class I device can produce a letter from the FDA stating the product is approved. This is simply the nature of a broad swath of FDA regulation from food and supplements to OTC drugs and Class I devices.
As experience and knowledge about a device increase within the FDA the original classification can be adjusted through the process of reclassification. Changes in classification are based on the FDA’s receipt or collection of new information about a device. This is typically something like an adverse event report or serious injury. Reclassification may be initiated by the FDA or in response to an outside petition to change a device’s classification by regulation.
Regulation differs from enforcement. Remember imported products are held to a higher standard and Warning Letters too informal for judicial review. Regulation refers to the formal process of issuing a rule, inviting public comment and feedback, and finalizing a regulation with a new title and CFR section.
Medical device regulation is a specialized filed where it is easy to become befuddled and confused. By looking in the right places and placing enforcement actions in the proper context, the picture becomes clearer. In a complex field of federal regulatory law be sure to look to qualified regulatory attorneys for guidance on device classification and the impact, if any, of new enforcement actions. While there is nothing precise or perfect in the process, but neither is there anything inherently nefarious or illegal.
- Read enforcement actions like Import Alerts and Warning Letters with caution because they are context and company specific and too informal to be new regulation or policy;
- Look to the CDRH and CFR for product classification and public, finalized, regulation and not state laws on professional licensing;
- When working with Class I device remember that the FDA does not provide an approval letter, but instead relies on manufacturers and sellers to document device classification; and
- The nature of regulatory law is intentionally ambiguous, which means (a) penalties for non-compliance are limited to Warning Letters and not criminal or civil penalties (e.g. non-compliance is not “illegal” per se), and (b) experienced regulatory attorneys can make the best sense of the complex field of law and regulation.
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