Who needs to list medical devices with FDA?

All domestic and foreign establishments that manufacture or distribute medical devices in the United States generally must list their marketed devices with FDA.

Is medical device listing required every year?

Yes. Medical device listing is typically done annually at the time of establishment registration renewal to keep FDA records current.

Can medical device listing be updated?

Yes. Device listings should be updated whenever there are changes to marketed devices, device names, models, or labeling.

What if I don’t list my devices with FDA?

Failure to properly list medical devices may result in compliance action by FDA and affect the ability to legally market or import devices in the United States.

Can FDA Registration Assistance complete my medical device listing?

Yes. FDA Registration Assistance provides professional support for completing and submitting medical device listing records.

Medical Device Listing l FSVP Experts

Q: What is medical device listing?

Medical device listing is the process of submitting device product records to FDA to identify the marketed medical devices associated with an establishment registration.

Fee: $449 Each Product

FDA Medical Device Listing Services

Most medical device establishments that are required to register with the U.S. Food and Drug Administration (FDA)must also list the medical devices they place into commercial distribution, including devices manufactured exclusively for export. This requirement is known as Medical Device Listing.

Medical device listing allows the FDA to identify the generic categories of devices an establishment manufactures or markets and is governed by 21 CFR Part 807.

What Is Medical Device Listing?

Medical Device Listing is the process by which registered establishments provide the FDA with information about the types of medical devices they manufacture, distribute, or process.

Important points:

Listing is required for most device establishments
Devices produced solely for export must also be listed
Listing keeps the FDA informed of the device categories in commercial distribution
Listing does not mean FDA approval or clearance

Device Classification & Product Codes

Each medical device listed with the FDA must be associated with a generic device classification.

Generic device categories are defined in Title 21 of the Code of Federal Regulations (CFR), Parts 862–892, or by an FDA-assigned device name
Each regulation number or device name is associated with one or more FDA product codes
Product codes further define the device’s intended use and technological characteristics

Example:

Manual Surgical Instruments for General Use
21 CFR 878.4800
Associated product codes include:

GAB – Disposable suturing needle
GDX – Scalpel
HTD – Forceps
HRQ – Hemostat

Medical Device Listing Is Not FDA Approval

Listing a medical device with the FDA does not constitute approval or clearance of either the device or the establishment.

Unless a device is specifically exempt, premarket authorization is required before a device may be commercially distributed in the United States.

This may include:

Premarket Notification (510(k))
Premarket Approval (PMA)
Other applicable FDA pathways

Exempt Devices & Limitations of Exemption

Some medical devices are exempt from the 510(k) Premarket Notification requirement, but all exemptions are subject to limitations.

Limitations of exemption are outlined in 21 CFR xxx.9, where “xxx” corresponds to the device classification part (e.g., 862.9, 864.9, etc.)
It is the manufacturer’s responsibility to ensure the device meets exemption criteria
If a device exceeds the limitations of exemption, a 510(k) submission is required
The device may not be marketed until the FDA issues a clearance letter

Medical Device Listing Assistance Services

FDA Registration Assistance provides professional support to help medical device companies properly complete their FDA Medical Device Listings.

Our services include: