FDA Label Reviews
for Medical Devices

Are you a medical device (or other products) manufacturer looking to sell your devices in the United States, then irrespective of your establishment status, the same regulatory compliance has to be followed when labelling your products if you want to receive approval from the FDA. At Cert3global, we provide a labelling guidance service to decrease your chances of rejection.

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Do you know one of the major reasons the FDA rejects a medical device is “Labelling”?

A large percentage of device rejections and detentions are a result of improper labelling. The Food and Drug Administration has strict regulatory requirements that need to be fulfilled before the label is approved. It involves far more than simply stating what the device does and what directions are to be followed.

The stakes are high in medical devices,which can alter the life of the user (patient) in both a positive way and at worst negative way. Hence, labelling becomes an important bridge to cross before the consumer or supplier has enough confidence in the device to make purchases.

The FDA wants the content of the label to be precise, especially when it comes to the display of chemicals, safety data, and bad effects. Hence, it is the responsibility of manufacturers to comply with these requirements or hire a competent and experienced agency that can point out where the scope of improvement is and suggest crucial corrections to increase the chances of approval.

We at Cert3global understand the sensitivity and importance of a good product label and help our clients by providing labelling services to ensure their label complies with FDA regulations and the whole effort is not wasted just because of labelling. Contact us now to increase the chances of your approval.

Cert3global can help you with the Labelling of :

  • Medical devices
  • Food
  • OTC (Over the Counter) Drugs
  • Cosmetics
  • Toys
  • Dietary Supplements

Our Review Process (as per FDA Standards) :

  • Label Content verification
  • Font size
  • Format
  • List of ingredients
  • Claims

General Elements of Labelling Required For Medical Devices:

1. Medical Devices
  • Usage Instructions: Provision of adequate directions for use as necessary.
  • Consumer Complaints: Information on a domestic entity to address consumer complaints.
  • Warnings: Inclusion of any other relevant warnings.

It’s important to note that for medical devices, the requirements may change following the device’s classification, making it one of the more complex commodities to label. Ensuring compliance with the latest regulations is crucial for the proper use and safety of medical devices.

2. Foods
  • Nutritional Information: Display of Nutrition Facts Panel, unless exempt.
  • Ingredients: Complete listing of ingredients.
  • Allergen Information: Declaration of allergens, unless exempt.
  • Claims:Any special health or dietary claims.

3. Over-the-counter (OTC) Drugs
  • Usage Directions: Clear instructions for use, including the purpose, signs, symptoms, and warnings.
  • Ingredients: Listing of drug ingredients.
  • Consumer Complaints: Contact information for a domestic entity for filing complaints.

4. Dietary Supplements
  • Labelling: Supplement facts similar to nutritional labelling.
  • Allergen Information: Declaration of allergens.
  • Ingredients: Listing of all ingredients.
  • Consumer Complaints: Contact information for a domestic entity for filing complaints.

5. Cosmetics
  • Ingredients: Declaration of all ingredients.
  • Net Contents: The amount of product.
  • Warnings: Any necessary warnings.