Allay Consulting August Newsletter: FDA & Cannabis-Infused Medical Devices
FDA & Cannabis-Infused Medical Devices – What You Need to Know
The Center for Device and Radiological Health (CDRH) is the Food and Drug Administration (FDA) center responsible for overseeing medical devices. Before medical devices can be sold to consumers, the FDA must grant those companies approval to ensure safety and effectiveness. Although some medical devices are exempt from premarket approval, all devices regulated by the FDA shall abide by their current Good Manufacturing Practices (cGMP).
FDA’s definition of a medical device is long, but specific…Straight from the FDA’s website, medical device is defined as:
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Medical devices can include any of the following: MRI machines, x-rays, LASIK surgical machines, acupuncture needles, bandages, electric toothbrush, tampons, etc.
It’s comforting that a regulatory body has oversight of these products! But what about hemp and marijuana infused medical device products? Are these items allowed or even regulated? The answer is complicated…yes and no. Before getting into that regulatory web, we first need to quickly review common infused medical device products.
Is your cannabis infused product considered a medical product or medical device by the FDA?
It’s not typical to see cannabis infused medical devices, but a few we’ve seen introduced into commerce include: metered dose nasal inhalers, tampons, vaginal/rectal suppositories, personal lubricants, and the most concerning, — intravenous applications.
We are obligated to remind readers to please consult your physician prior to choosing an infused medical product.
Federal Allowances vs. States Allowing Infused Medical Devices
As you can gather, the FDA has intense oversight for medical devices. Combine this oversight with the FDA not officially allowing hemp infused products, and things start to get tricky. Interestingly, some states allow marijuana medical device products. For example, Colorado’s Marijuana Enforcement Division (MED) allows the sale of “audited products” which are marijuana-infused metered dose nasal spray, vaginal administration, and rectal administration.
These items include metered inhalers, tampons, suppositories, etc. The MED has strict compliance requirements for these products that include an independent third-party audit by a certified quality auditor or GMP auditor, various standard operating procedures, product lab testing, personnel training, strict traceability, etc. And now further entanglement, Colorado’s Department of Public Health and Environment (CDPHE) regulates hemp infused products and does not allow hemp infused medical devices/products.
What does this mean for the industry?
While we are still bracing for FDA’s cannabis regulations, the industry is in a grey space. We suggest following FDA’s guidance on medical devices and your specific state requirements. This means steering clear of infused medical devices unless your state or county has a written allowance.
Need further guidance? Our Certified Quality Auditors are well adapted to assisting the cannabis industry for topics such as audited products. If you need assistance with any existing FDA requirements or unique state cannabis regulations, please feel free to reach out!
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