Is my product a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated?

Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.

Cosmetics v. Drugs

Let's start with some basic definitions:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the federal Food and Drug Administration (FDA) define products by their intended use.

  • Cosmetics are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. According to the FDA, among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
  • The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

The FDA states:

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

According to the FDA, intended use can be shown by:

  • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials.
  • Consumer perception, which may be established through the product's reputation.
  • Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use.

Thus, certain claims "may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic....Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells."

An example where ingredients cause the product to be considered a drug, is fluoride in toothpaste.

The FDA has different labeling requirements for drugs and cosmetics.

  • Approval requirements for drugs vs. cosmetics: there is no premarket approval system for cosmetic products or ingredients (with the exception of color additives).
  • Drugs usually must receive premarket approval by the FDA or conform to final regulations that specify conditions where they are generally recognized as safe and effective,but not misbranded.  (There are separate rules for over-the-counter (OTC) drugs).
  • Good manufacturing practices (GMPs) are different: there are strict GMP requirements for drugs and none for cosmetics (other than ensuring that the products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics.
  • FDA maintains the Voluntary Cosmetic Registration Program7, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
  • Labeling requirements are different. The FDA has a Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."

The FDA has a webpage that serves as a portal for regulatory information regarding FDA regulation of drugs.

Included is information about drug applications for over-the-counter (OTC) drugs.  The FDA states:

Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids,  instead of individual drug products.  For each category, an OTC drug monograph is developed and published in the Federal Register.   OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling.  Many of these monographs are found in section 300 of the Code of Federal Regulations1.  Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval.   New prescription drugs, on the other hand, require pre-approval before they can go on the market.  These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.   New products that conform to a final monograph may be marketed without further FDA review.  Those that do not conform  must be reviewed by the New Drug Application2 process.  A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.

According to the FDA, 6 out of 10 drugs are OTC drugs.

Medical Devices

The first thing is to determine if you have a medical device.  The FDA notes that the definition of medical devices is very broad:

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 products3 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 as a medical device and is subject to premarketing and postmarketing regulatory controls.

A medical 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."

The FDA has a wealth of information to consider before marketing a medical device on its FDA webpage dedicated to medical device regulation.

Medical Device v. Drug

The FDA notes that the difference between a medical device is its intended use: if the intended use is through chemical action or being metabolized by the body, the product is usually a drug.

Note that the FDA regulates drugs through its Center for Drug Evaluation and Research (CDER), but regulates biological products and blood banking equipment through its Center for Biologics Evaluation and Research, and veterinary products through its Center fo Veterinary Medicine (CVM).

If you have a medical device, the next thing is to determine its device classification (i.e., whether it is Class I, Class II or Class III), and whether your device is "substantially equivalent" (SE) to an already legally marketed medical device that is not subject to premarket approval (PMA).  You determine this by filing a 510(k) submission to the the FDA to demonstrate substantial equivalence.

There are two powerful ways to begin to research substantial equivalence, in preparation for the 510(k) submission:

Search the 510(k) Medical Device Classification Database

Search the Device Classification Panels in the Code of Federal Regulations (CFR)

Devices are organized in 21 CFR, Parts 862-892 into 16 medical specialty panels, such as anesthesiology, cardiovascular, chemistry, dental, ear nose and throat, gastroenterology and urology, general and plastic surgery, immunology, microbiology, and so on.

For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required. If your Class I (or certain class II) device is exempt, subject to the limitations on exemptions, from the 510(k) process, this will be stated in the classification regulation. However, other General Controls such as registration and listing, labeling, and good manufacturing practices apply. If you have a Class III device requiring premarket approval (PMA) the FDA has guidance on obtaining a PMA.

Dietary Supplements

The term "dietary supplement" was defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994.  The FDA states the definition for consumers as follows:

A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

The FDA provides several guidance documents for industry professionals seeking assistance with labeling, claims, substantiation, and other regulatory issues.

If you have a product and are unsure whether it might be regulated by the FDA as a cosmetic, drug, medical device, dietary supplement (or food), biological, or otherwise, the FDA website is a good place to start.  You should also contact an experience FDA attorney to help you create legally compliant labeling, advertising, and marketing materials for your product.  Our law firm has FDA expertise and can help provide legal guidance for you from concept to market.

 
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