by Regulatory & More May 13, 2020

Three Essential Steps to Getting a Device to the U.S. Market

Step 1. Verify that your product is a medical device/IVD

First, define the intended use and indications for use of your product.

As a reminder:

Intended Use: The general purpose of the device or its function. This includes the indications for use. (How the device is designed to be used)

(i.e. for a surgical catheter: The product is intended to be used for the destruction of tissue by freezing)

Indications for use: Describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended. (For what purposes the device is expected to be used).

(i.e. for a surgical catheter: The product is indicated to be used for the treatment of cardiac arrhythmias)

Then, check if your product meets the definition of a medical device as per the Food, Drug, and Cosmetic Act (FD&C Act) below.

Medical Device Definition (incl. IVDs):

The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-
(1) recognized in the official National Formulary, or the United States Pharmacopeia, 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 360j(o) of the of the FD&C Act.
Section 201(h) of the FD&C Act

If your product does meet the definition of a medical device you will be subject to provisions of the FD&C Act that must be met before a product can be marketed. (Go to Step 2)

If your product does not meet the definition of a medical device, it may be regulated by another Center within the FDA. FDA advises to contact the Center you believe the most appropriate to your product and discuss with it.

Center for Biologics Evaluation and Research (CBER) regulates biological products.
Center for Drug Evaluation and Research (CDER) regulates human drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product may be considered a drug.
Center for Veterinary Medicine (CVM) regulates products intended for animal use.
Center for Tobacco (CTP) regulates tobacco products.

Step 2. Determine how to classify the medical device/IVD

The second step would be to determine if an appropriate product classification exists for your product.

There are 3 regulatory classes of medical devices in the U.S. Each of them are linked to requirements (called Regulatory Controls) and regulated by the FDA’s Center for Devices and Radiological Health (CDRH).

1. Class I General Controls (low risk medical device)
With Exemptions
Without Exemptions
2. Class II General Controls and Special Controls (moderate risk medical device)
With Exemptions
Without Exemptions
3. Class III General Controls and Premarket Approval (high risk medical device)

The classification determines whether a submission is required and/or which type of submission is appropriate. It also determines the type of regulatory control necessary for ensuring safety and effectiveness (S&E) (S&E is based on the level of risk of the medical device).

An important point for the classification of the device is to take into account its intended use and its indication for use and similar products already approved or cleared in the U.S. market.

Determine the classification of your device

To determine if an appropriate product classification exists for your product, the FDA recommends different methods:

Method 1: Search the Product Classification Database

Go to the Product Classification Database and try to determine if there is an existing product classification that applies to your product. Search by keyword(s) , product code, regulation number, or device class.

Method 2: Search for Similar Devices

Try to identify a similar device legally marketed in the United States. Then, go to the databases below and search for it FDA letter or order that permits market authorization. The information in the letter will help you determine the classification of your device.

Premarket Approval (PMA) Database

This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).

Premarket Notification 510(k) Database

This database includes releasable 510(k) information.

De Novo Database

This database includes De Novo classification orders and transparency summaries.

Humanitarian Device Exemption (HDE) Database

This database includes devices with HDE approval, and includes the approval order, Summary of Safety and Probable Benefit, and labeling for the approved device.

Important Note: Most Class I and some Class II devices may not be listed in the databases referenced above because they are exempt and do not require the FDA’s review before marketing.

Method 3: Search for Similar Devices by Device Listing

Try to identify a similar device legally marketed in the United States. Then, go to the FDA’s Establishment Registration and Device Listing database, and review the device listing information.

Method 4: The Device Panel

As described by the FDA, If you know the Device Classification Panel (medical specialty) to which your device belongs you would be able to find the device classification.

Go to the listing for that panel in the Product Classification Database and identify your device and the corresponding regulation. Most of the time the device classification is mentioned.

If the device classification is not mentioned, go directly to the CFR and find the classification for your device by reading through the list of classified devices.

Each classification panel in the CFR begins with a list of devices classified in that panel.

Each classified device has a 7-digit number associated with it (e.g., 21 CFR 880.2920 – Clinical Mercury Thermometer).

Once you find your device in the panel’s beginning list, go to the section indicated: in this example, 21 CFR 880.2920 .

In this example, the panel’s beginning list describes the device and says it is Class II.

Similarly, in the Product Classification Database under “thermometer”, you’ll see several entries for various types of thermometers.

The three letter product code, FLK in the database for Clinical Mercury Thermometer, is also the classification number which is used on the Medical Device Listing form.

Unable to make a device determination for your product?

If you are unable to make a device determination for your product after following the methods above, the FDA recommends to contact the Division of Industry and Consumer Education (DICE).

Then, if you are still unable to make a device determination for your product, the FDA recommends to contact the Device Determination mailbox at DeviceDetermination@fda.hhs.gov. You will need to provide the following in your email: Intended Use, physical description and mechanism of action, any claims you intend to publicly make about the product and your contact information.

The 513(g) Request

The 513(g) Request is a formal process for information regarding the device determination or classification and the regulatory requirements, from the FDA, that may be applicable to a particular device.

FDA Guidance document: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012).

Step 3. Select and submit the appropriate request(s) / application(s)

Different types of pre-market submissions and FDA interactions exist in the U.S. Each of them has specific documentation requirements.

The two most common applications/submission are the PMA and the 510(k):

Premarket Approval (PMA) applications

The PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Premarket Notification (510(k)) submissions

The 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA)

Most Class I are exempt from premarket notifications 510(k) and are subject to General Controls only.
Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketed. This database includes releasable 510(k) information.
Most Class III (high risk) devices require PMA before they may be legally marketed.

Other types of requests/interactions/submissions available (non-exhaustive):

Evaluation of Automatic Class III Designations (De Novo requests)
Investigational Device Exemption (IDE) applications
Humanitarian Device Exemption (HDE) applications
Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW)
Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
Accessory Classification Requests
Biologics License Applications (BLAs)
Pre-Subs Meetings

Download the Summary Chart

510(k)Classification Definitions IVD MD PMA U.S.