FDA Device Advice for CAM Professionals

Those seeking to provide health and wellness services with medical devices can find help on the FDA website.

Called Device Advice, the FDA website provides a plethora of resources.

Keep in mind that the federal Food and Drug Administration regulates the device itself, whereas state law regulates the practice of medicine and the question of who can deliver health care services using various therapies and modalities (including devices). In other words, state law will regulate the scope of practice of a given provider (massage therapist, naturopathic physician, acupuncturist, nurse, psychologist), and whether an unlicensed provider such as lay naturopath, homeopathy, or energy healer can deliver health care services. For example, the non-licensed provider should beware of the state law prohibition on the unlicensed practice of "medicine," as broadly defined in the applicable state statute and subsequently interpreted by the state's courts (and enforced through its DA's and attorney general).

Further, FDA Device Advice is usually addressed to the manufacturer, not to the practitioner. But recently many clients have called our law offices wanting to know whether they can be the first to import a certain "energy" device from an overseas manufacturer. In such case they have been looking to step in the shoes of the manufacturer and become an agent for the manufacturer and would have to walk through the FDA regulation.

One of the first questions under the federal regulation is: am I dealing with a "medical device"?

Device Advice explains:

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls.

To clarify, the FDA goes to the federal statute which tells us that a device is:

"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 any of it's 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."

In short, if the machine is not intended by the manufacturer to be used for "diagnosis," "cure" and the like, and does not fall within one of the other exceptions, then the FDA does not regard it as a device. Note that "intention" is a tricky concept. Merely changing the words around (i.e., "assessment" rather than "diagnosis;" "assessing chakra and meridian energies" rather than "diagnosing disease") does not necessarily mean that the device will be regarded as other than intended to "diagnose" or "cure." If a certain machine, for example, has testimonials where clients make incredible claims about the beneficial effect on an existing disease (say cancer), it might be difficult not to read an intended cure into the manufacturer's marketing and distribution. Similarly, the statutory term "mitigation" is fairly broad ... most of these instruments are only commercially successful because manufacturers and practitioners hope, or give clients the hope, that there will be some mitigation of the disease process, if not outright cure. Again, the testimonials that typically accompany sales brochures or websites will suggest this.

Also note that the device definition applies whether the machine is something conventional or complementary and alternative -- whether it is a tongue depressor or a sauna, a thermometer or something that purports to read chakras and meridians.

As to the difference between a device and drug, the Device Advice website explains:

This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research (CBER). FDA's Center for Veterinary Medicine (CVM) regulates products used with animals. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about the products they regulate. In cases where it is not clear whether a product is a medical device there are procedures in place to use DSMICA Staff Directory to assist you in making a determination.

Once you know you're dealing with a medical device, you'll need to classify the device:

The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

Class I General Controls
   With Exemptions
   Without Exemptions
Class II General Controls and Special Controls
   With Exemptions
   Without Exemptions
Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.

The 510(k) is a submission to the FDA "to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA." PMA stands for premarket approval and requires a much longer (and more expensive) submission to the FDA should the FDA not find 'substantial equivalence' in response to the 510(k) submission.

There are various possible exemptions to the 501(k) requirement, and one can write a "513(g)" letter which asks the FDA to recognize the exemption. Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)] requirements subject to the limitations on exemptions. You can find a list of categories here. Some CAM devices (or devices used by complementary care providers) will found under physical medicine (s. 890). For example: "massager, therapeutic, electric." A favorite of some naturopaths is here: "Nonpowered sitz bath." Even the cane is listed (890.3075).

There is further explanation on the website as to how the FDA classifies the device (again, whether for a therapy labeled conventional or alternative and complementary):

Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product...In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

Note that the General Control will apply to all medical devices irrespective of classification.

The three steps - determining whether you have a medical device, determining how the FDA will classify the device, and developing data to submit the 510(k) application or PMA (as required), are laid out in the FDA's Device Advice page on Getting to Market.

As noted, our law offices help clients in the medical device domain as well as those seeking to offer non-device, complementary care therapies. Navigating through the FDA hurdles is not insurmountable, but it does require care and attention to detail. Fortunately the Device Advice website is a good resource through which clients can educate themselves as to some of the basic regulatory requirements that might apply to their proposed business situation.
Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on holistic, alternative, complementary, and integrative medical therapies. The law firm represents medical doctors, allied health professionals (from psychologists to nurses and dentists) and other clinicians (from chiropractors to naturopathic physicians, massage therapists, and acupuncturists), entrepreneurs, hospitals, and educational organizations, health care institutions, and individuals and corporations.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploring legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, and herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion. This book completes the cycle begun in Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), and continued in Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

As of 2007, health care and corporate attorney Michael H. Cohen has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C., and to the Bar of England and Wales as a Solicitor (non-practicing). For more information, see the FAQs for the Law Offices of Michael H. Cohen.