United States| Regulatory Market Profile

United States medical device regulatory profile

Updated January 1, 2023

US Medical Device Regulatory Agencies

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FDA news

Medical Device Regulations & Guidance Documents in the United States

FDA Medical Device Classifications

In the United States, device classification is based on risk level and regulatory controls.

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Classify your medical device (FDA)

Devices are generally classified as follows, but there are exceptions to each classification rule:

Class I devices - Class I devices are “not intended for use in supporting or sustaining life” and do not “present a potential unreasonable risk of illness or injury.” Class I devices are required to comply with General Controls only.

Examples: tongue depressors, oxygen masks, adhesive bandages

Class III devices - Class III devices “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.” Class III devices not only require compliance with General and Special Controls, but must obtain pre-market approval before being marketed in the U.S.

Class II devices - Class II devices present a higher level of risk and include devices “for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class II devices are required to comply with General and Special Controls and almost always require a 510(k) submission.

Examples: catheters, blood pressure cuffs, contact lenses

FDA Medical Device Market Requirements

There are four major steps to bringing a medical device to market in the United States:

Classify your device.

Select and prepare the appropriate premarket submission. Use of the eSTAR electronic submission program is currently available for 510(k) and De Novo submissions, but is not mandatory until October, 2023.

Send your premarket submission to the FDA and interact with the agency during review. Most class II and class III devices (and some class I devices) will require a premarket quality system inspection as defined in 21 CFR part 820.

Comply with all applicable regulatory controls.

Submission types:

A 510(k) submission is used to obtain market clearance for most class II devices, along with some class I and class III devices. A 510(k) submission requires identification of a substantially similar "predicate" device that is already on the market.

A Premarket Approval (PMA) is required for any device that sustains or supports life, is implanted, or presents a "potential unreasonable risk of illness or injury" (most class III devices). The PMA process is the most stringent regulatory process, typically requires human clinical trial data, and is designed to prove that a new device is safe and effective.

A De Novo application can be made for novel device with a lower risk level. Novel devices without existing predicate devices on the market are automatically classified as class III devices. A successful De Novo application will reclassify the device.

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FDA: 510(k) Clearances

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FDA: Premarket Approval (PMA)

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FDA: De Novo Classification Process

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FDA Product Classification database

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How to find and effectively use predicate devices

Additional information:

Any organization (establishment) involved in the production or distribution of a medical device intended for use in the United States must register annually with the FDA.

Foreign manufacturers and distributors can register directly with the FDA.

There is a third-party review program available, but it is optional.

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How to study and market your device

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Device registration and listing

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21 CFR 807
Establishment registration

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FDA Online Account Administration (OAA) - Device registration website

FDA Post-Market Requirements

The FDA defines post-market surveillance requirements in 21 CFR 822 through implementation of section 522 of the FD&C Act.

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21 CFR Part 822
Post-market Surveillance

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Guidance for Post-market Surveillance under Section 522

FDA UDI Requirements

The United States mandates both UDI labeling and submission of UDI data in the GUDID (Global Unique Device Identification Database).

The FDA announced in July of 2022 that GUDID requirements would not be enforced for most Class I devices.

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Unique Device Identification System (UDI)

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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

Standards and Conformity Assessments in the U.S.

The FDA’s Standards and Conformity Assessment program is designed to promote patient safety, advance regulatory science, and support the least burdensome regulatory framework.

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Standards and Conformity Assessment Program

Manufacturers are encouraged to use FDA-recognized consensus standards in premarket submissions, but conformance to these standards is voluntary.

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Recognized consensus standards

2024 fees for registering medical devices in the United States are as follows (see MDUFA amendment for full list, including fees for supplements):

Activity

Standard Fee

Small business fee

Annual Establishment Registration Fee

$7,653

No waivers or reductions

510(k)

$21,760

$5,440

PMA, PDP, PMR, BLA

$483,560

$120,890

De Novo Classification Request

$145,068

$36,267

Annual fee for periodic reporting on class III devices (PMAs, PDPs, PMRs)

$16,925

$4,231

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Medical User Fee Amendments (MDUFA)

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Who Must Register, List, and Pay the Fee

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Reduced Medical Device User Fees: Small Business Determination