How to Use FDA Classifications to Select Skin and Wound Care Products Protection Status

by the WoundSource Editors

Health care professionals have a major responsibility for assuring patient safety and quality of care when making wound care product selections or recommending treatment options. This is particularly true for wound care.

One component in this is understanding the process used by the Food and Drug Administration (FDA) to classify products. The FDA determines what testing is required for each product category; what claims can be made; the indications and contraindications for each product; and ingredients required for specific claims. Unfortunately, clinical education does not usually include a basic course in the FDA classification system and regulatory requirements.

The FDA was created in the late 1800s as a direct result of misrepresented claims, indications for use, and a lack of contraindications or cautions. In the early 1900s, the agency created a classification system that assigned the level of scrutiny required for each product classification it designated.

FDA Classification of Skin and Wound Care Products

Classification assigned by the FDA depends on a product's intended use and the level of potential risk to the end user. The classifications most commonly associated with products used for skin and wound care include (but are not limited to):

  • Implantable devices;
  • Prescription drugs;
  • Over-the-counter (OTC) drugs;
  • Cosmetics; and
  • Personal care products

A number of skin and wound care products are regulated. Once a clinician knows the FDA classification of a particular product, it is fairly simple to determine what claims, indications for use, and label information is required. This can be extremely helpful and may even be the key factor in determining if a product is appropriate for a particular patient situation.

Selecting a Skin and Wound Care Product Based on FDA Monograph

Here is an example: You need to select a barrier product for skin protection. There are a number of FDA monographs on OTC drugs related to skin barriers. They have been published in the Federal Register. In this monograph, the FDA itemizes the legitimate claims that a manufacturer with a product, formulated as outlined in the monograph, can make. Examples of these approved claims for a skin barrier include the "treatment of chapped, chafed, and irritated skin." Indications for use would be for the same conditions, but with contraindications for use on full-thickness wounds, burns, and conditions not responding after 10 days of treatment.

So, to select a true "skin barrier," you should look for a product formulated according to the monograph. Then, a claim regarding "treatment" can be made. If a manufacturer of a product makes a treatment claim, the product must be formulated as a drug. An active ingredient is required if a product is a drug. This is also true for OTC products. The active ingredient(s) must be one or more of those listed in the monograph. Examples of active ingredients for skin barrier products include: dimethicone, zinc oxide, and petrolatum.

Not only must the product be formulated with the active ingredient as listed in the monograph, that ingredient must also be in the concentration percentage as specified by the FDA. Some manufacturers list the concentration percentage of the active ingredient(s) on the label to demonstrate compliance with the monograph specifications.

For Your Information: What's Included on Product a Label

So, now you are looking at a skin barrier product that is formulated with concentration percentage of an active ingredient as specified in the FDA monograph published in the Federal Register. That product is an OTC drug. The FDA also specifies what information must be on the product label. For an OTC drug, the following must be listed on the container and the product package:

  • Instructions for use
  • Claims statement
  • Indications
  • Cautions or contraindications
  • Application instructions
  • Active ingredients
  • Other (inactive) ingredients
  • Storage information
  • Accidental ingestion information
  • Manufacturing company information
  • General use instructions

Indications for use (as described in the monograph), are the uses that the FDA recognizes as being safe and effective. Using a product for other indications not listed on the label, while not against the law, may be construed as "off label use". It could possibly subject the clinician making the recommendation to scrutiny in the case of any adverse event.

Health care professionals can make sound, science-based decisions if they understand the FDA regulatory process and the potential ramifications of product selection.


Editor's Note: This article was originally published on November 6, 2008 and has been updated for accuracy and comprehension.

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