Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Software as a medical device: how it is regulated

United States · Food and Drug Administration · Software as a medical device

Other routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Software as a medical device: how it is regulated in United States?

Software that meets the device definition goes through the normal device routes (510(k), De Novo or PMA) according to its risk class. Some software functions were removed from the device definition by law, and the agency focuses its oversight on software that poses a greater risk if it does not work as intended. A predetermined change control plan can cover planned updates. Software functions, including mobile apps and AI-enabled functions, that diagnose, treat or prevent disease.

What are the steps of the Software as a medical device: how it is regulated?

1. Decide whether the software function is a device; 2. Find the risk class and route; 3. Use the matching device route; 4. Plan updates with a change control plan (optional).

Outcome: Clearance, De Novo grant or approval through the matching device route.

Legal basis: Sections 201(h), 520(o) and 515C of the Federal Food, Drug, and Cosmetic Act

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Decide whether the software function is a device
2. Find the risk class and route
3. Use the matching device route510(k), De Novo or PMA, with the eSTAR template where required.
4. Plan updates with a change control plan (optional)only in some cases

Requirements

What the applicant must provide or meet

Eligibility

Function-specific policyThe rules apply to each software function, whatever platform it runs on.

Other

Device route and format510(k) and De Novo submissions use the eSTAR template, unless exempted.
Predetermined change control plan(optional)A cleared or approved plan allows planned changes without a new submission.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in United States: Premarket notification (510(k)), De Novo classification request, Premarket approval (PMA), Humanitarian device exemption, Class I devices exempt from premarket notification, Breakthrough devices program, Emergency use authorization. See all routes on the United States page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.