United States| Regulatory Market Profile
Updated January 1, 2023
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.
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.
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.
FDA Post-Market Requirements
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.
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.
Manufacturers are encouraged to use FDA-recognized consensus standards in premarket submissions, but conformance to these standards is voluntary.
FDA Medical Device Registration Fees
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
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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