U.S. Food and Drug Administration (FDA) regulations for marketing medical devices in the United States are extensive and can be difficult to understand. Registrar Corp, an FDA consulting firm that helps medical device companies comply with FDA regulations, compiled a list of ten tips to help medical device companies navigate FDA requirements.
1. Start researching early. Marketing a medical device in the United States can be a lengthy process depending on the classification of the device and whether there are comparable devices on the market already.
2. Determine the product’s intended use and ensure that FDA considers the product to be a medical device. FDA defines a medical device as “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 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.”
If the product is considered to be a medical device, review the Code of Federal Regulations (CFR) as it pertains to medical devices and radiation emitting products (21CFR Parts 800-1050).
3. Determine how FDA may classify the device. Devices can be classified as Class I (Low Risk), Class II (Moderate Risk), or Class III (High Risk). These classifications are different from European Union classifications. Generally, the classification of a device determines what premarket requirements it is subject to, which leads to the next tip.
4. Determine whether the product requires premarket notification (510(k)), requires premarket approval (PMA), or is exempt from FDA premarket review. Most class I devices are exempt, most class II devices require a 510(k), and most class III devices are subject to PMA, but there are some exceptions. For example, FDA proposed to exempt certain class II devices from 510(k) requirements in September 2014.
5. If the product requires a 510(k) or PMA, gather the necessary data. Compile the application and submit it to FDA. 510(k) submissions should be submitted at least 90 days before the applicant intends to market the device. It’s common for a 510(k) to consist of over a hundred pages as they require detailed information about the device, as well as documents such as proposed labels. PMAs require extensive scientific data that proves the device is safe and effective for its intended use. Allow ample time to prepare a PMA, as they are expensive and may take years to complete. Wait to market a device in the US until FDA’s clearance or approval letter has been obtained.
6. Register the manufacturing establishment and submit device listings to FDA for each device produced. The fee to register a device establishment in fiscal year 2015 is $3,646. Device establishments must re-register annually between October 1 and December 31.
7. Ensure compliance with Quality System Regulations, also known as current good manufacturing practices (CGMPs), which can be found under 21 CFR part 820. CGMPs ensure that the design and the manufacture of devices meet consistent quality standards.
8. Determine whether the product requires a Unique Device Identifier (UDI). In September 2014, FDA finalized a rule that requires most medical devices to bear a UDI. Compliance dates for UDI requirements depend on the classification of a device.
9. Consider whether the product is more than just a medical device and thus subject to additional requirements. If a device is combined with a drug and/or a biological product, it is considered a combination product. If a device contains an electronic circuit and generates radiation, it is considered a radiation-emitting product. Combination and radiation-emitting products are subject to additional FDA requirements.
10. Once a device is on the market, be aware of postmarket surveillance requirements. One postmarket surveillance requirement is Medical Device Reporting (MDR). Manufacturers, importers, and device user facilities are required to report to FDA when a device malfunctions or is suspected of causing serious injuries or death to users. Other postmarket surveillance requirements include tracking systems, registering establishments where devices are produced and distributed, and conducting postmarket surveillance studies.
Registrar Corp assists medical device companies with FDA regulations. The firm can help companies register with FDA and list their devices, as well as review their device labels for FDA compliance. Registrar Corp also assists with UDI and 510(k) requirements. For questions about or assistance with FDA regulations for medical device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at https://www.registrarcorp.com/livehelp.
This blog was originally published as a press release.