FDA Microneedling Regulations Status Update

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.

Pointers

  • 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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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

43 Comments

  1. Microneedling Classification Order - FDA Atty on April 2, 2020 at 4:27 pm

    […] 2018. The Draft Guidance document is available here. (Previous posts on microneedling can be found here and […]

  2. AMY on March 20, 2019 at 10:56 pm

    how can i find out what micro needling devices are FDA approved in canada?

    • Marc Sanchez on March 22, 2019 at 9:16 am

      Thank you for your comment. Health Canada regulates medical devices and is the best resource for your question.

  3. Novah on September 9, 2018 at 12:05 pm

    I have a salon and Day spa in Missouri and I have ordered a derma pen and want to start performing the service. I am wondering if Missouri has regulations or laws on who can administer this service ?

  4. Sherry on September 3, 2018 at 12:47 pm

    can Estheticians perform microneedling treatments in the state of Florida while working in a dermatologist office?

  5. Wendy Bryan on August 9, 2018 at 10:27 am

    I’m an esthetician in Texas and I can’t find anything on the legalities of microneedeling/ medical settings. I’m certified in microneedeling but the owner of my spa doesn’t want to offer it because she thinks it has to be performed in a medical setting. Is this true and why would my esthetician school offer it if it can’t be performed? I myself am trained on medical and cosmetic depth of microneedeling and have seen an outstanding improvement in my own skin. Why am I not able to help others get these results?

    • Marc Sanchez on August 15, 2018 at 10:38 am

      Wendy,

      The FDA has designated microneedling as a prescription medical device. This means your state board of medicine would have rules on whether a physician can delegate use of the device and whether a non-physician can use the device. In classifying microneedling as a medical device the FDA did recognize the benefits but also the severe risks posed by unregulated devices. Hence, the change.

  6. Gabe Hernandez on August 1, 2018 at 4:46 am

    Hi Marc,

    Do you have any information as to whether aestheticians performing this in there own solo place of practice with no MD is ok? I am in AZ can not find much information at all and I am hearing mixed information from the state board. Thank you in advance.

    • Marc Sanchez on August 15, 2018 at 10:39 am

      The FDA has designated microneedling as a prescription medical device. This means your state board of medicine would have rules on whether a physician can delegate use of the device and whether a non-physician can use the device.

  7. marcus on June 21, 2018 at 1:05 pm

    In Arizona do you know what board I would call to ask micro needling regulation questions for setting up a Med Spa? Thank you!

    • Marc Sanchez on August 15, 2018 at 10:39 am

      The FDA has designated microneedling as a prescription medical device. This means your state board of medicine would have rules on whether a physician can delegate use of the device and whether a non-physician can use the device.

  8. Gigi on January 15, 2018 at 1:02 pm

    Hello .. I am trying desperately to make sense of micro needling and dermaplaning rules in Connecticut.
    In a day spa setting can an Esthetician perform these services or not?
    Esthetician are not licensed here. There isn’t a scope of practice to adhere to.

    • Marc Sanchez on January 15, 2018 at 2:31 pm

      Gigi,

      Thank you for your comment. Unfortunately, our firm works on FDA issues of microneedling not on the state issues of use. You may want to contact your State Board of Medicine to ask if microneedling constitues the practice of medicine.

  9. Mary Gervasini on December 21, 2017 at 6:59 pm

    Hello, I currently work in CT as an aesthetician in a Dermatology office. I use the derma pen now. Will all class 1 devices be banned once these company’s come out with their version of what may become class 2?

    • Marc Sanchez on December 28, 2017 at 10:46 am

      Hello Mary,

      Yes, it is highly likely that once a microneedling pen is approved as a Class II, then any microneedling device claiming to be Class I will not only be misleading but also adulterated as an unapproved medical device. The FDA Microneedling Guidance made clear that these devices are medical devices subject to pre-market clearance. Clear risks were identified with these devices which would be demonstrated as properly controlled in a pre-market application.

  10. frezna on December 4, 2017 at 8:13 pm

    Hello, I currently run a store that looking to sell these.

    From my research anything that has a needle length of 0.25mm and below seems to be ok.
    However, I am wondering about the other needle lengths such as 0.5mm, 0.75mm, 1.0mm?

    Those go past the epidermis of the skin and therefore fall under the class of “medical device”
    Yet I’m not sure if these can still be sold in the US or not. Can’t find anything that forbids them from sales but can’t find anything that specifically says they are restricted either. I tried looking through the database and guidance docs on the FDA website but couldn’t find information specific enough. Would you happen to know if you can actually sell these legally?

    Thanks and appreciate it
    Frezna

    • Marc Sanchez on December 5, 2017 at 2:08 pm

      The recently issued Microneedling Guidance will contain all the direction you need. In it there is a discussion on what is a medical device needle depth and what are medical device claims (conversely identifying cosmetic depths and claims). I would strongly recommend a detailed review of the Guidance.

  11. Mark Herbes on December 3, 2017 at 12:06 pm

    I just looked this up on the fda website in a table under Title 21 CFR 26….it’s the 878.4200 GFE listing listed above. Unless I’m not using my legal “eye” properly, this product requires a premarket eval before selling

    “Table 1–Class I Products Requiring Premarket Evaluations in the United States, Included in Scope of Product Coverage at Beginning of Transition Period 1” -april 2017

    So possible approval in the future maybe.

    • Marc Sanchez on December 5, 2017 at 2:03 pm

      Bear in mind for a Class I device, the “pre-market” step is simply registration and listing. It is important to verify the classification is correct but otherwise no pre-market submission like a 510(K) is required.

  12. Rain on November 7, 2017 at 8:01 am

    Can spas perform microneedling in Ga without the supervision of a physician ?
    There are several in my area doing microneedling and they are not med spas and not practicing under a doctor??

    • Marc Sanchez on November 10, 2017 at 1:31 pm

      You will need to contact your state licensing board. The FDA does not regulate who can use a medical device beyond designating it OTC or Rx.

  13. Amber House on October 26, 2017 at 1:50 pm

    I notice that Eclipse and Dermapen are not able to “sell” the product in the US due to the FDA blacklisting them. However, I know some physicians who still use the devices since they purchased them before the “ban.” Is that dangerous territory for the physician to use such products or would it be “playing it safe” to only use products that have been approved or gone through the red tape.

    • Marc Sanchez on October 26, 2017 at 3:43 pm

      Thank you, Amber for your comment.

      It is not accurate to say these products were blacklisted or banned. As previously discussed on the Blog an FDA Warning Letter is a non-binding recommendation of compliance. If the FDA wanted to ban a product it would seize the product or seek an injunction. Neither of those have happened for any microneedling device.

      It is also not accurate to say any product is approved. The majority of microneedling devices are registered as Class I, which may be subject to change under a new FDA Guidance.

      In general, to mitigate risks ask for quality documents from a supplier like sterility assurance or needle quality. At the moment, that is the best approach.

  14. FDA Microneedling Guidance - FDA Attorney on September 14, 2017 at 3:48 pm

    […] 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here and here. Only a summary of the microneedling guidance posted today. Below is the constituent […]

    • Konrad on October 22, 2017 at 11:43 pm

      Hey Mark,

      If I don’t make any claims that this product is a medical device will I be able to sell devices that only penetrate top layer. Can I market them as cosmetic devices?

      • Marc Sanchez on October 23, 2017 at 8:52 am

        Hello Konrad,

        You’ll need to follow both portions of the guidance to be a cosmetic. The guidance is as much about design and technology as it is about claims.

        You can e-mail me at msanchez@fdaatty.com with any questions.

  15. Tonya Struthers on April 11, 2017 at 7:03 pm

    What about the (original) use of Tattoo Machines instead of DermaPen types of devices?

    • Marc Sanchez on April 12, 2017 at 8:49 am

      As eith any FDA classification question the focus is on ‘intended use.’ A medical device is typically use to treat/mitigate/cure a disease or condition but also includes any product that has an impact on the structure/function of the human body.

      Tattoo machines don’t meet this definition. They are for cosmetic purposes. The tattoo needles deliver ink which changes the appearance of the skin but does not impact its structure or how it functions. Therefore the tattoo gun when used for tattooing is not within the FDA’s jurisdiction.

  16. Sabiel Lopez on March 31, 2017 at 4:06 pm

    If I have an LLC Can I sellA micro needling devices? Assuming I got them ordered from an FDA registered establishment, legally able to manufacture these devices. Do I have to register my business to distribute/market micro needling devices?

    • Marc Sanchez on March 31, 2017 at 4:16 pm

      You will need to complete a review to determine if it is a medical device and what medical device product code to use. Then you will need to complete a medical device establishment registration prior to beginning any sales or marketing. You can send me an e-mail at msanchez@fdaatty.com if you would like more details.

  17. celia turtocski on March 21, 2017 at 1:52 pm

    I have a day spa in st. augustine, fl and would like to offer these treatments. Does a physician have to be on board for the use of the roller? I have investigated the different sizes and would like to purchase at least four different rollers. Is there a FDA approved package of 4 available for purchase?

    • Marc Sanchez on March 21, 2017 at 7:23 pm

      The use of a medical device and corresponding treatment is a state law question based on what the State Board deems practicing medicine. The FDA establishment and device listing database will have all listed microneedling devices.

  18. Kishwar Mudassir on February 20, 2017 at 2:37 pm

    I want to know which companies or brands are approved by FDA for Collagen Induction Therapy e.g Derma pen etc

  19. maria sanabria on September 6, 2016 at 4:20 pm

    i am an aesthetician in florida and need more info on microneedling and the depth we can used please let me know

    • Marc Sanchez on September 6, 2016 at 4:38 pm

      Hello Maria –

      Currently the FDA is working on a Guidance document for micrnoneedling. Until that time there is not FDA requirement on needle depth. It would be up to the physician to determine the appropriate depth.

      • Maria on September 6, 2016 at 5:21 pm

        I don’t work under a Medical dr i work on a regular spa what is the Save to work with

        • Marc Sanchez on September 7, 2016 at 12:27 pm

          Hello Maria –

          I cannot advise you on what needle depth to work at. I do recommend using only a FDA registered device and one that does not have a history of adverse events or enforcement action.

  20. FDA Microneedling Presentation - FDA Attorney on April 28, 2016 at 9:31 am

    […] ASAPS invited me to speak on FDA regulation of microneedling. As I’ve addressed in previous posts and articles there are several questions about the FDA and micro […]

  21. Reilly on January 16, 2016 at 1:29 pm

    Hello, I’m a Certified Medical Laser Tech in Arizona. I am not an aesthetician. Can I lawfully perform microneedling at a medspa facility under the supervision of a medical director?

    • Marc Sanchez on January 19, 2016 at 10:42 am

      Reilly –

      Thank you for your comment. The question of what constitutes the practice of medicine and whether a license is required is a State law issue. Your doctor should be able to tell you if microneedling constitutes the practice of medicine in Arizona.

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