By Priya Bhutani — Obtaining market approval for a medical device from the US FDA seems arduous and frightening and most manufacturers do not know where to even begin. Medical devices are subject to general controls of the Federal Food Drug & Cosmetic (FD&C) Act, which are the baseline requirements necessary for performance, proper labeling, and monitor in the US market. Summarized are the 3 steps to obtain market approval in the US.
STEP 1:
Ensure your product meets the definition of a “medical device”. The product may be a drug or a biologic, which is regulated by a different provision in the FD&C Act. Or your product may be a medical device with an electronic radiation-emitting component, subjecting it to additional requirements.
Per the FDA, a medical device is “an instrument, apparatus, implement, machine, 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 a 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 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 the classification of your device (I, II, or III). The device classification based on the risk of the device will determine the marketing process (exempt, 510(k), or PMA) needed to obtain FDA approval for marketing. Most class I devices are exempt; most Class II devices require premarket notification or 510(k), and most Class III devices require premarket approval or PMA.
STEP 3:
Prepare the marketing application by providing performance data or clinical data if applicable. Most PMAs require clinical data in which case a clinical trial would be conducted in accordance with the Investigational Device Exemption (IDE) regulations. Also, register your establishment with the FDA. All Class I, exempt devices, must also register their establishment and list their devices with the FDA. As a manufacturer, assure the device is properly labeled and complies with the FDA’s labeling requirements. By applying for market approval in the US, the device manufacturer is attesting they meet the FDA’s quality system regulations.
Once the device is approved and on the market, manufacturers have to perform post-market surveillance.
