Product Classifications and FDA Guidelines: What Every Wound and Skin Care Professional Needs to Know Protection Status
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by Kathi Thimsen RN, MSN, WOCN

Why do we have the FDA

In the late 1800s the government saw the potential danger that “snake oil” salesmen posed to society. Potions and elixirs were said to calm women prone to hysteria during the pre-menstrual cycle or cure headaches. Some of the most dangerous elixirs claimed to calm colicky babies and irritable children. These potions and elixirs were formulated with water, alcohol, and in some cases, poisons like toxic herbal extracts and tar.

In an effort to promote safety and inform the public of benefits and dangers, the Food and Drug Administration (FDA) was established. The FDA provides regulation, oversight, and enforcement of safety standards for:

  • Product development
  • Testing
  • Reporting
  • Manufacturing
  • Packaging
  • Labeling
  • Post market surveillance with compliance monitoring

FDA regulation of Over the Counter Skin Products

The FDA oversees foods, drugs, and medical devices. Drugs overseen by the FDA include over the counter (OTC) medications that do not require a prescription, as well as prescription medications and controlled substances. Medical devices are also regulated and classified according to intended use, mode of action, and external or internal placement or use.
Skin and wound care products on the market today vary in classification, including classification of skin and wound products that are formulated and produced as cosmetics. Cosmetics are not regulated as medical products. The ingredients used in cosmetics are subject to safety, efficacy, and specific formulation requirements.

Cosmetics are products formulated and intended to improve the appearance of the skin. Labeling must meet requirements that include claims and intended use of the product. Directions for application and ingredients may be listed along with the manufacturer name and place of production. Ingredients listed on the label or package insert may include all ingredients by percentage of concentration from highest to lowest. An active ingredient is not a component of the cosmetic formulation. An example of a cosmetic skin product is a skin cleanser or moisturizing lotion.

OTC drugs are available for purchase without a prescription. Intended use, method of action, directions for use, application/administration, and dosage are all required for the label or package insert. Labeling claims are limited to improving the condition related to the intended use. An OTC drug lists an active ingredient on the label and insert. The active ingredient that is identified must be an approved ingredient and be used within an approved range of percentage of concentration. An example of an OTC drug product used in skin and wound care is barrier ointment.

FDA regulation of Prescription Skin Care Products

Prescription drugs are regulated under a classification system. Skin and wound care products are not controlled substances (narcotics) but must provide active ingredient(s) information and disclose a pharmacologic mode of action. Intended use, administration, dosage, contraindications and potentially adverse reactions must be listed on the label or package insert. Wound care products such as Accuzyme, Santyl or Regranex are drug products.

FDA regulation of Medical Devices

Medical devices are classified as products manufactured under FDA device guidelines. They are subject to pre-marketing testing for safety and efficacy. Devices are also monitored post-marketing for compliance, safety, and performance. Gauze, hydrogels, hydrocolloids, negative pressure wound closure devices, staples, and sutures are examples of medical devices.

Clinicians and FDA Classifications

Understanding FDA classifications, labeling, claims, ingredients, and use in practice will enable a clinician to appropriately and safely identify products. Familiarity with product classifications leads to knowledge about:

  • Formulations
  • Ingredients
  • Possible side effects
  • Allergic responses
  • Safe and intended use

Clinicians should be attentive to the implications of using skin and wound care products in an “off label” application. Knowing the ingredient components also enables the prescriber to be aware of potential contraindications like combination treatments or mixing of a variety of agents in a protocol.

Information on cosmetics, OTC and prescription drugs, labeling, ingredients and regulations may be found at The Federal Register also is the source for all regulations and compliance issues.

About The Author
Kathi Thimsen RN, MSN, WOCN is a leader in the field of wound and ostomy care, publishing articles, presenting at conferences nationally and internationally, and serving on numerous committees and education boards including the International Association of Forensic Nurses Ethic Committee.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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Also important to note is that non-bioengineered allograft tissues (like skin allografts used in wound care) are regulated by the FDA for "homologous use" (skin replacing skin, bone replacing bone, etc). So this type of skin substitute is not FDA "cleared" per se, nor is it a medical device, but it is allowed to cover any wound type as long as it is used in this homologous fashion.

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