How do I sell medical products in the United States?

Obtaining market authorization for a medical products from the US FDA is difficult and daunting, and most manufacturers are unsure where to begin. Medical devices are subject to general restrictions under the Federal Food, Drug, and Cosmetic (FD&C) Act, which are the minimum criteria for performance, correct labeling, and monitoring in the US market. The three processes to obtaining market approval in the United States are summarized in this article.

STEP 1:

Ascertain if your product satisfies the definition of a “medical device.” The product might be a medicine or a biologic, which are governed by separate provisions of the FD&C Act. Alternatively, your product may be a medical device with an electronic radiation-emitting component, in which case it would be subject to extra restrictions.

A medical device, according to the FDA, is “an instrument, equipment, implement, machine, contrivance, implant, in vitro reagent, or other similar or related object, including a component part, or accessory that is:

Ø Recognized in the official National Formulary, the United States Pharmacopoeia, or any supplements to these,

Ø Designed for use in the diagnosis of a disease or other conditions, or in the cure, mitigation, treatment, or prevention of sickness in humans or animals.

Ø Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its 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.”

STEP 2:

Determine your product’s categorization (I, II, or III). The marketing method (exempt, 510(k), or PMA) required to gain FDA permission for marketing will be determined by the product categorization based on the risk of the device. The majority of Class I devices are exempt; the majority of Class II devices require premarket notice or 510(k), and the majority of Class III devices require premarket approval or PMA.

STEP 3:

Prepare the marketing application by submitting performance or clinical data, if appropriate. Most PMAs require clinical evidence, in which case a clinical study would be done in compliance with the IDE rules. Register your business with the FDA as well. All Class I, exempt devices, must also register with the FDA and list their gadgets. As a manufacturer, you must ensure that the device is appropriately labeled and meets the FDA’s labeling criteria. By filing for market approval in the United States, the device maker certifies that it complies with the FDA’s quality system standards.

Manufacturers must conduct post-market surveillance once the item has been certified and placed on the market.

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