FDA Medical Devices Requirements
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 any of 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 (i.e. is not a drug).
Regulatory Classification of the Device.
In order to know what FDA requirements need to be met for your device, you need to know how FDA classifies the device. FDA classifies a medical device as class I, class II, or class III based on the risks associated with the device, with class III being the highest risk category. A tongue depressor is an example of a class I device (the lowest risk category). An example of a class II device is a pregnancy test kit. An example of a class III device is an implantable cardiac pacemaker.
If FDA has not classified the device, a company may need to apply for FDA’s premarket approval of the device. For premarket approval, FDA evaluates the device’s safety and efficacy and then classifies the device. Or, for low-risk devices, FDA may authorize marketing the device via the de novo classification pathway which does not require submission of a 510(k) as described later in this article.
Establishment Registration
The manufacturer, initial importer, contract sterilizers, specification developers, re-labelers, and any other establishments involved in the processing, development, or distribution of medical devices must be registered with the FDA as medical device establishments. Some of these establishments are required to pay FDA an annual user fee which is expected to increase each fiscal year.
Medical device establishment registrations must be renewed annually and establishments that are required to pay the user fee must pay the fee each year as well. For a complete list of facilities required to register as medical device establishment and facilities that must pay the user fee, visit FDA’s registration and listing webpage at: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.
It may take several weeks or longer for FDA to issue a medical device establishment registration number. However, the FDA’s online registration system automatically generates an owner/operator number for the company when the registration is electronically filed. The owner/operator number may be used in lieu of the registration number while the company is waiting to receive its registration number. For importing medical devices, the Customs filer/broker must submit the registration number to FDA for every shipment but can submit the owner/operator number in lieu of the registration number if the company has not yet received the registration number.
US Agent for Foreign Establishments
Registered facilities in foreign countries must have a US agent. The US agent must be located in the US and receive communications from FDA and assist FDA with scheduling any inspections of the foreign facility.
Official Correspondent
The owner or operator of a medical device establishment (domestic or foreign) must designate an official correspondent for the company. For foreign companies, the official correspondent may or may not be the same entity as the US agent. The official correspondent is the point of contact with FDA for issues regarding the annual registration of the establishment and the listing of its devices. The official correspondent receives communications from FDA and must provide FDA the names of all the company’s officers, directors, and partners if FDA requests that information.
Device Listing
The manufacturer, foreign exporter, and certain other medical device establishments are required to list their medical devices with FDA. Each listed device is assigned a device listing number. For importing a medical device, the Customs filer/broker must submit the manufacturer’s device listing number for each shipment of the device.
For a complete list of companies required to list their medical devices with FDA, visit FDA’s registration and listing webpage at: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.
Premarket Notification (“510k”)
For most class II medical devices, FDA requires the manufacturer to notify FDA of its intent to market the device at least 90 days in advance. This premarket notification is often referred to as a “510k”. The 510k must show that the device is substantially equivalent to a device already on the market in terms of safety and efficacy. (The device must be at least as safe and effective as an equivalent device that has already been legally marketed.) A device may qualify for an abbreviated form of a 510(k) application known as an “abbreviated 510(k)”.
Premarket Approval
As mentioned earlier, a product that is not substantially equivalent to a product that has already been legally marketed in the US and which is not classified by FDA’s medical device regulations may require submission of an FDA premarket approval application which FDA evaluates to determine if the product is safe and effective. All class III devices require FDA premarket approval in order to be marketed in the US.
Investigational Medical Devices
A medical device that will be only be used in a clinical study (not intended for commercial use) may be distributed under an Investigational Device Exemption (IDE) application approved by FDA. IDE devices are assigned an IDE number. For importing IDE devices, the Customs filer/broker must declare the IDE number to FDA for each shipment.
Label Requirements
Ensure the product label complies with all federal labeling requirements such as having a properly declared statement of identity, net quantity of contents, intended use and indications for use, directions, contraindications, warnings, precautions, business name and address (manufacturer, distributor, or packer), country of origin, date of issuance, and Unique Device Identification (UDI).
Good Manufacturing Practices
The manufacturer must comply with FDA’s medical device Quality System (QS) regulation and Good Manufacturing Practices (GMPs). The GMPs include requirements for the methods, facilities, and controls used in the designing, manufacturing, labeling, packing, storing, installing, and servicing of the devices.
California Proposition 65
For products marketed in California (including packaging), Proposition 65 requires businesses to provide warnings to the consumers about any substances in the products that California believes causes cancer or reproductive harm including birth defects. California lists these substances in its “Prop 65 list” ( https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those listed substances, companies can usually meet the Prop 65 requirements by placing the appropriate warning statement on the product’s label.