Nov 26, 2019

Manufacturers of medical devices in the US are required to register their products with the Food and Drug Administration (FDA), which subjects certain devices to stringent requirements that can include clinical testing. Because many regulatory agencies in other countries offer expedited approvals for devices previously cleared by FDA, companies with aspirations to global reach generally find it in their best interests to begin with US market access. The FDA classifies medical devices based on both their intended use and indications for use, using a scale that distinguishes between three levels of perceived risk (Classes I, II, and III).

Bringing a new device to market requires planning ahead for the necessary work to obtain and safeguard FDA approval. A serious mistake could cause the FDA to reject your application or withdraw a product from the market. To avoid failure, your first step should be learning about how the registration process works and where your company might need help.

What does the US FDA consider a medical device?

While the term “medical device” may call to mind high-tech diagnostic instruments and surgical implants, it applies equally to basic implements used by the medical industry such as tongue depressors and stretchers. The US FDA regulates medical devices similarly to how it governs drugs, although the medical device regulatory scheme developed considerably later. In 1976 Congress passed amendments to the Federal Food, Drug, and Cosmetic Act (FD&C or FDCA), of which Section 201(h) defined 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:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. 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
  3. 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 its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o).

While certain types of software are exempted from this definition by section 520(o) of the FD&C, many software components of physical devices as well as standalone software builds are classified as medical devices by the FDA and must be submitted for registration.

What are the different FDA device classes?

The FDA recognizes three different risk-based classes of medical devices, while jurisdictions such as Canada and Japan use four and the European Union identifies more rigidly defined subclasses. The broad constitution of medical device classes in the US, along with the fact that market access requirements can differ for products falling into the same class, mean that the general classification of a device cannot be taken as a complete roadmap for registration.

Class I devices are considered low-risk, often consisting of simple designs without moving parts; these are not intended to directly save or sustain life. The requirements applied to Class I devices are known as “general controls.” Examples of this device class include adhesive bandages, scalpels, and manual stethoscopes. Most Class I devices can be registered with the FDA without the requirement of obtaining clearance, but some require 510(k) Premarket Notification.

Class II devices are medium-risk, often with more complex designs but whose failure would be unlikely to pose an immediate risk of serious injury or death. General controls are deemed insufficient to regulate Class II devices, which call for “special controls” such as labeling requirements, performance standards, and post-market surveillance (PMS). Examples include endoscopes, powered wheelchairs, syringes, and total joint implants. Some Class II devices only need to be registered, but many require clearance; the typical path to market for devices in this class is the 510(k) Premarket Notification.

Class III devices are high-risk and could lead to serious medical complications including death if they fail. Class III devices are required to undergo the Premarket Approval (PMA) process unless they can be shown to be “Substantially Equivalent” to an existing approved (“predicate”) device. “Preamendments” devices, or devices that were on the market prior to the issuance of this classification scheme, may also be exempt if the FDA has not specifically designated them as requiring PMA. Examples of Class III devices include cardiac pacemakers, deep-brain stimulators, breast implants, and heart valves.

How do I determine the classification and exemption status of my device?

The FDA regulations applying to different medical devices can be found in the Code of Federal Regulations (CFR) Title 21 Parts 862 to 892. These are divided into numerous products types and subtypes which can be intimidating to navigate but are intended to provide exhaustive coverage for new medical devices. If you find the pertinent regulation, it will identify the classification of your device and whether it is exempt from requirements like 510(k) and PMA.

The FDA’s product classification database provides product codes and registration guidelines for existing medical devices. You can search this database by product type, as well as by regulation number if you found this in the CFR. If you have a product that you want to bring to market and hope to list it as “Substantially Equivalent” to a predicate device, you can find it here. If you are unable to locate an exact predicate device, you may submit a 513(g) “Request for Information" to the FDA, asking them to issue a ruling of the classification, regulation number, and product code of your device. An FDA guidance document on 513(g) requests is available here.

New medical devices receive a default Class III designation by the FDA, but there is an alternative pathway in place for products that are clearly not high-risk. If no predicate device can be established, you may make a de novo submission. The FDA then has 120 days to consider whether to reclassify your device as Class I or II and issue a new regulation number and product code. Your device will remain Class III if the submission is rejected. An FDA guidance document on de novo submissions can be found here.

Where do I go from here?

While there are a number of further considerations that medical device manufacturers will have to address (e.g., usability testing, quality system management, designating an FDA Official Correspondent), it is impossible to formulate a complete plan for market access until the device classification is ascertained. Accomplishing these earliest steps of the FDA approval process correctly can be critical for getting to market quickly and not having to start over from scratch.

Related US FDA medical device classification resources from Emergo by UL: