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The Importance of FDA 510(k)s When Looking for Your White Label Partner

Finding just the right White Label partner for your health and wellness brand can often be a difficult process. Aside from all of the hurdles your new product faces in terms of formulation and marketing, your partner is also required to navigate through a labyrinth of systems designed by the FDA in order to obtain certification for the product’s launch and marketability. As any brand expert launching a medical device might tell you, this is a task that is far easier said than done.

In order for your medical device (which generally includes health and wellness products) to be sold on shelves, 510(k) clearance is required. In the case of a white label partnership, however, there are some specific considerations to be made to ensure a smooth brand launch and proper regulatory maintenance.

 What is a 510(k)?

A 510(k) is a special premarket notification that indicates a class I, II, or III medical device has received marketing clearance for safe and effective use by the general public. Each submission is compared to another device already marketed in the U.S. with the same intended use (known as the predicate) to determine if it is “substantially equivalent” (SE). If it is found to be substantially equivalent, the device is allowed to be distributed commercially and marketing practices may proceed.

A substantially equivalent device is one which is deemed as safe and effective as other similar products available or has technological similarities with the same intended use. No matter what, the submission must prove to be just as good, if not better, than something already being sold where safety and efficacy are concerned. If the submission meets these criteria, it is labeled substantially equivalent and given 510(k) certification.

However, in the event your product is not found to be substantially equivalent for any reason, it must instead undergo a process directly through the FDA. This can take one of two routes, depending on the class of the medical device in question.

Class I and Class II medical devices (which are likely your concern in the health and wellness market, involving products such as personal lubricants and skin lotions) must have a De Novo Request submitted. The De Novo process ensures that novel medical devices are properly risk-assessed and fit for distribution. Once the FDA reviews the request and finds the product adequate and reasonable for safety assurance, it will grant your product the 510(k) certification.

Meanwhile, Class III medical devices (which normally involve life-support or products which have substantial health-related risks associated with their use) must receive premarket approval (PMA) in order to be marketable. This process is much more stringent than the De Novo request and generally requires a great amount of scientific evidence and data to validate the safety of the product.

Why are 510(k)s Important For White Label Partners, Specifically?

In a white label partnership, another company is providing the formulation behind your health and wellness brand. Unlike private labels, which help manufacture and distribute your own solution, a white label partner manufactures their own creations to be used for your brand.

As a result, it’s absolutely essential that your partner already has 510(k) clearance for their serum. Otherwise, the product cannot be marketed until the process with the FDA is completed. On average, receiving a 510(k) can take 5 months, which might throw a budding brand’s plans into disarray if not taken into account—assuming there are no hiccups in the clearance process that could postpone the certification further. What’s more, different medical device types will take varying lengths of time to clear, meaning more complex formulations might not be cleared for a long time.

Equally as important is your white label partner’s dedication to FDA auditing. Because they are the ones who created the formula, they (or you, in collaboration with them) should be prepared to face FDA audits. Manufacturers of Class II or Class III medical devices are audited by the FDA once every two years, which provides enough time to plan for the inspection. Failure to do so can delay, postpone, or even outright halt distribution of the product, so coordinate to make sure your white label partner is prepared.

Product updates and changes will also typically require new 510(k) clearance. If you decide to alter a specific aspect about your brand’s formula or design, your white label partner must submit them and retrieve another 510(k) before the changes can be finalized in the marketable product. Agility is key to making quick decisions that could benefit both your brand and your company—but your white label partner needs to be in the same boat as you.

Gaining and maintaining 510(k) clearance for health and wellness formulations requires a great deal of proactivity between both the OEM and the white label partner. A fluid partnership with parameters that are clearly defined by a contract will allow the two parties the flexibility to stay agile in the market space. This is why a trustworthy, reputable white label partner that values a solid relationship with your brand is the best choice when it comes to handling 510(k) certification, as well as all of the FDA processes that are involved.

Still Searching for a White Label Partner?

If you’re looking to white label to get your health and wellness brand off the ground, CC Wellness offers adept medical device regulatory navigation, strategic management of Amazon businesses, and prime marketing strategies—all from our field experts to you. In fact, CC Wellness has received 25% of all 510(k)s given by the FDA in our category since 2015, and the number is still going up. During the year of 2020 alone, we secured 26% of all 510(k)s issued by the FDA.

Our entire white label package is available through our Make WAVES brand service. With our numerous science-based formulations being backed by a team of industry veterans, we can ensure the success of your brand by implementing the best techniques and practices behind each milestone of the product launch. And best of all? We work alongside you and your brand vision, just like a teammate should. 

Interested in a quality white label partnership? Visit our Make WAVES homepage and download our free brochure for more information.

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