The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory Considerations for Microneedling Devices.”
First, what is a Draft Guidance? FDA issues guidance documents to industry (and internally for its own staff) explaining the Agency’s current position on a regulatory question. Although FDA Guidance does not have the force and effect of law, it does outline the safe harbor boundaries for industry. A draft guidance is one that FDA is circulating around for comments from industry — curiously FDA has a long history of treating draft guidances as finals and industry members should take note.
In this draft guidance FDA asks and answers the following questions:
- What kind of microneedling instrument is regarded as a medical device under FDA’s jurisdiction?
- If a microneedling article is regarded as a medical device, what Pre- and Post-Marketing regulatory obligations apply?
Second, this is not FDA’s first time talking on the subject – it has done so in the past – just not very clearly. For instance, it has issued warning letters and placed foreign microneedling device manufacturers on import alert (representing a statement from FDA that it believes certain products imported from certain foreign manufacturers/exporters appear to violate the Federal Food, Drug, and Cosmetic Act (FDCA) and therefore are subject to Automatic Detention). See Import Alert 89-08, Detention Without Physical Examination of Devices without Approved PMA’s or IDE’s and Other Devices Not Substantially Equivalent or Without a 510(k).
This new guidance is designed to clarify and set the ground rules for microneedling products. In the Draft Guidance, FDA avoided discussing when a microneedling product is inherently a medical device by sheer fact that it stabs and punctures the skin – although we at FDAImports.com and their affiliated attorneys have in the past had fruitful conversations with FDA on this point.
Instead in this guidance, FDA stuck with laying out its opinion that any microneedling product with the following uses is a medical device:
- Treats scars (e.g., acne scars, atrophic scars, hypertrophic scars, burn scars)
- Treats wrinkles and deep facial lines
- Treats cellulite and stretch marks
- Treats dermatoses
- Treats acne
- Treats alopecia (hair loss)
- Stimulates collagen production
- Stimulates angiogenesis
- Promotes wound healing
What does this mean?
FDA’s position is that microneedling medical devices are subject to FDA’s pre-market notification (510(k)) requirements, at least, and in our view should be subject to FDA’s de novo classification review process. Companies in this industry should expect FDA to increase its inspections and evaluation of imported products. We expect FDA will seek to add foreign manufacturers of such devices onto its import alert (number 89-08) covering medical devices lacking required PreMarket Approvals, Investigational Device Exemptions or 510(k)s, and domestic firms can expect warning letters.
Now that this Draft Guidance is out, class-action plaintiff attorneys may increasingly target companies marketing their devices for intended uses that FDA has clearly designated as Medical Device claims and yet which lack approved PMAs or cleared 510(k)s. Without such clearances, money from the sale of the devices in California or New Jersey or other class-action friendly jurisdictions can become targeted proceeds derived from false and misleading marketing practices in a class action lawsuit.
What should you do?
Well, call us.
And in lieu of that, anyone making, importing, distributing, marketing or selling microneedling devices must evaluate whether their products are, by design and/or intended uses, medical devices under FDA jurisdiction.
Companies should immediately evaluate all their marketing materials to determine whether their claims are likely to be construed as medical device claims.
Companies that intend to stay in the market can obtain from FDA written confirmation that their devices are not medical devices. We can assist with that process as we have for our clients in the past.
Companies wishing to obtain FDA clearance or classification of their devices should contact us as well, as we need to work quickly to ensure the requisite Design Controls are in place to construct a successful filing to FDA.
In any event, hoping FDA does not notice you is not a strategy for success. It might be strategy for FDA, FTC, or state enforcement or litigation, but it will not be successful for you in the long run. If you believe in your product, the best course of action is to prove it to the right people, with the right data/evidence and regulatory process, and obtain assurances for your clients, your employees and the future of your business.
If you have additional questions regarding FDA’s Draft Guidance, contact us at contact@fdaimports.com or 410-220-2800.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
