What Is SaMD? FDA Rules for Software as a Medical Device

SaMD, or software as a medical device, is software with a medical purpose that works without being part of a hardware medical device. FDA requires 510(k) clearance, a De Novo grant or PMA approval before you sell it in the US, unless an exemption or enforcement discretion policy applies.

Key takeaways

• Section 520(o) of the FD&C Act takes five kinds of software out of the device definition. They include administrative, wellness and some clinical decision support software.
• FDA updated two software policies in January 2026. General wellness changed on January 6. Clinical decision support (CDS) changed twice, most recently on January 29.
• Of the 1,614 AI-enabled devices on FDA's list, 1,553 were cleared through a 510(k), 40 were granted De Novo and 21 were approved through PMA.
• By our count of openFDA data, FDA cleared 187 510(k)s in 2025 under product codes with "software" in their name, up from 109 in 2023. Applicants outside the US received 112 of them.
• From October 1, 2026, a 510(k) costs $28,653, or $7,163 for a small business. Annual establishment registration costs $13,785.

This guide is chapter 1 of our SaMD & AI Track. The track also covers risk categories, IEC 62304, change control plans, cybersecurity and pathway choice.

What does SaMD mean?

SaMD means software as a medical device. FDA uses the definition agreed by the International Medical Device Regulators Forum (IMDRF). SaMD is "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device" [1].

IMDRF formed its SaMD working group in 2013, chaired by FDA, to agree this definition and a common risk framework [1]. FDA describes three types of software related to medical devices [1]:

Type	What it is	Example from FDA
Software as a medical device (SaMD)	Software that is a medical device on its own	Software that lets a smartphone show MRI images for diagnosis
Software in a medical device (SiMD)	Software that is integral to a hardware medical device	Software that drives the motors and medication pumping in an infusion pump
Software used to make or maintain a device	Manufacturing or maintenance software, which is not SaMD	Software that monitors x-ray tube performance to plan its replacement

FDA's own umbrella term is "device software function". It covers both SaMD and SiMD, and the same policy applies whatever platform the software runs on [5]. For the third group, see our guide to validating AI tools under the QMSR.

Is my software a medical device?

Your software is a medical device if its intended use fits the definition in section 201(h) of the FD&C Act and no exclusion applies [2, 3]. FDA judges intended use from what you say about the product, its design and how you sell it (21 CFR 801.4) [6].

Work through these steps in order:

1. Write your intended use in one sentence. Name the condition, the user and the output. A step counter and an atrial fibrillation detector can share code, but only one makes a disease claim.
2. Check the five exclusions in section 520(o)(1). If one applies in full, that function is generally not a device [2].
3. Check FDA's enforcement policies. For some low-risk device functions, FDA does not intend to enforce its requirements. One example is software that helps patients self-manage a condition without specific treatment suggestions [5].
4. Separate the functions. In a product with device and non-device functions, FDA regulates only the device functions. It may still assess how the others affect them (section 520(o)(2)) [2].
5. Decide whether it is SaMD or SiMD. Software that a hardware device needs to perform its intended use is not SaMD, even if you sell it separately [1].
6. Find the product code. It gives you the class, the regulation and the pathway.

Which software is not a medical device under section 520(o)?

Section 520(o)(1) of the FD&C Act excludes five kinds of software functions from the device definition [2]. Section 3060 of the 21st Century Cures Act added it on December 13, 2016 [4].

Exclusion	What it covers	Where the limit is
520(o)(1)(A) Administrative support	Billing, claims, scheduling, business analytics, population health management and laboratory workflow	Must support the administration of a health care facility
520(o)(1)(B) Healthy lifestyle	Maintaining or encouraging a healthy lifestyle	Must be unrelated to diagnosing, curing, mitigating, preventing or treating a disease
520(o)(1)(C) Electronic patient records	Transferring, storing, converting or displaying the equivalent of a paper chart	Records must be created, stored, transferred or reviewed by health care professionals or people they supervise, and be part of certified health IT. The function must not interpret or analyze them for a diagnostic or treatment purpose
520(o)(1)(D) Lab and device data	Transferring, storing, converting formats or displaying lab test and other device data	Stops applying if the function interprets or analyzes the data
520(o)(1)(E) Clinical decision support	Software that supports a health care professional's decision	Must meet four criteria, covered next

The exclusions apply to functions, not whole products. One app can display lab results, which is excluded, and analyze ECG waveforms, which is a device function [2, 3].

When is clinical decision support software not a device?

CDS software is not a device only if it meets all four criteria in section 520(o)(1)(E) [2]. FDA explains how it reads them in its CDS guidance, last updated on January 29, 2026 [3].

1. It does not acquire, process or analyze a medical image, a signal from an in vitro diagnostic (IVD) device, or a pattern or signal from a signal acquisition system.
2. It displays, analyzes or prints medical information, such as a lab result or a clinical guideline.
3. It supports or provides recommendations to a health care professional (HCP) about prevention, diagnosis or treatment.
4. It lets the HCP independently review the basis for each recommendation, so the HCP does not rely mainly on it.

Three points in the guidance decide many cases. Software that gives a specific preventive, diagnostic or treatment output or directive fails criterion 3 [3]. But if only one option is clinically appropriate and the software otherwise meets the criteria, FDA intends to exercise enforcement discretion [3]. Recommendations to patients or caregivers, rather than HCPs, make the software a device [3]. Software for time-critical decisions does not meet criterion 4, because the HCP is unlikely to have time to review its basis [3].

Software function, from FDA's examples	FDA's view [3]
Recommends a specific FDA-approved antibiotic from a patient's symptoms, recent hospital stays and past antibiotic use	Enforcement discretion, if it otherwise meets the criteria
The same, but also analyzes spectroscopy data to diagnose a bacterial infection	Device
Flags drug-drug interactions using FDA-approved labeling and patient information	Not a device, if it also meets criterion 4
Analyzes an ECG waveform from an FDA-cleared device to detect atrial fibrillation	Device

Our article on what changed for CDS software in January covers the single-recommendation change in detail.

When is a wellness app or wearable outside FDA oversight?

A wellness product falls outside FDA's device oversight when it is intended only for general wellness and is low risk [4]. FDA's general wellness guidance, updated on January 6, 2026, sets out both tests [4].

Wellness claims cover general health, such as weight management, fitness, relaxation, sleep or mental acuity, with no reference to disease [4]. They can also say a healthy lifestyle "may help reduce the risk of" or "may help living well with" certain chronic conditions [4]. That link must be well understood and accepted. FDA's examples include high blood pressure and type 2 diabetes [4]. Low risk means the product is not invasive and not implanted. It also must not use a technology, such as lasers or radiation, that needs specific controls [4].

Some wearables that estimate body values can qualify. FDA may treat a non-invasive product that estimates blood pressure, oxygen saturation, blood glucose or heart rate variability as a wellness product [4]. Its outputs must be for wellness only. It must not substitute for an FDA-authorized device, prompt specific clinical action, or show clinical-style values that are not validated [4].

For products that estimate or show body values, FDA lists five things that rule out the wellness policy. They apply to the labeling, advertising, user interface or functionality [4]:

1. References to specific diseases, clinical conditions or diagnostic thresholds.
2. Alerts, alarms or prompts that recommend or require specific clinical action or medical management.
3. Treatment guidance meant to inform or direct medical management.
4. Claims of clinical equivalence, clinical accuracy, medical or clinical grade, or substitution for an FDA-authorized device.
5. Intended-use statements that explicitly target diagnosis, screening, monitoring or management of a disease.

A note suggesting a visit to an HCP is allowed [4]. It must not name a disease, give thresholds, call the output abnormal or act as an ongoing alert. Our guide on when a mobile health app needs FDA clearance walks through more examples.

See what changed in FDA’s wellness and CDS policies.

What is the difference between SaMD and SiMD?

SaMD performs its medical purpose on its own, usually on phones, computers or cloud servers. Software in a medical device (SiMD) is integral to a hardware device. That hardware needs it to do its medical job [1].

	SaMD	SiMD
Where it runs	General purpose computing platforms, which may sit inside a hardware device [1]	The device's own hardware, often as firmware [1]
FDA examples	Treatment planning software that supplies information to a linear accelerator; computer-aided detection software for breast cancer [1]	Motor control in an infusion pump; closed-loop control in a pacemaker [1]
Classification	Classified on its own intended use, as Class I, II or III [5]	Part of the hardware device, since the device definition covers components and parts [5]
Software documentation	FDA's 2023 premarket software guidance [6]	The same guidance, which also covers firmware [6]

One edge case is connected software. If the hardware does not need it to achieve its medical purpose, FDA's examples page calls it SaMD [1]. Software that supports or augments a device's performance may still be treated as an accessory [5].

How does FDA classify SaMD?

FDA classifies SaMD in Class I, II or III, like any other device, by intended use and risk [5]. The class comes from the device's classification regulation and product code, not from the IMDRF risk categories [5].

IMDRF's framework sorts SaMD into four risk categories. FDA's CDS guidance points to it for more on risk categorization [3]. Our guide to SaMD risk categories explains how the two relate.

Many software device types have their own regulation. These examples are all Class II with special controls [9, 12]:

Regulation (21 CFR)	Device type	Product code
870.2345	Electrocardiograph software for over-the-counter use	QDA
882.5801	Computerized behavioral therapy device for psychiatric disorders	PWE
882.5803	Digital therapy device for attention deficit hyperactivity disorder (ADHD)	QFT
884.5370	Software application for contraception	PYT
886.1100	Retinal diagnostic software device	PIB
892.2050	Medical image management and processing system	QIH, LLZ
892.2080	Radiological computer aided triage and notification software	QAS

To find yours, search FDA's classification database by device type, then read the regulation and its special controls. If you still cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [11].

If you would rather start from a plain description, try Complizen's free device check. It returns your likely class, candidate product codes with the regulation behind each, and possible predicates, from FDA's own databases.

For generative AI medical devices, FDA has published a separate discussion paper.

Is there a SaMD certification?

No. FDA does not certify software. It clears 510(k)s, grants De Novo requests and approves PMAs [9]. What people often call certification is that marketing authorization plus two ongoing duties:

• Registration and listing. Companies that make devices register their establishment and list their devices. This includes companies that develop specifications for a device another firm makes (21 CFR 807.20) [12]. The FY2027 annual registration fee is $13,785 [11]. Under 21 CFR 807.39, registration does not mean FDA approved your company or product [12].
• A quality system. The Quality Management System Regulation (QMSR), 21 CFR part 820, took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference [6].

Other markets run their own systems. FDA clearance does not replace CE marking in Europe, and CE marking does not replace FDA clearance.

Which pathway does SaMD take: 510(k), De Novo or PMA?

Most software devices reach the US market through a 510(k). On FDA's AI-enabled device list, 1,553 of 1,614 devices came through a 510(k) [9].

The other two routes are De Novo and PMA. A De Novo request covers a new low to moderate risk device type with no predicate, and a PMA covers Class III devices [5, 9].

A De Novo grant classifies a new type of device. FDA says devices classified this way can then serve as predicates for future 510(k)s [9]. Each device type below started with a De Novo and now has its own regulation with special controls [9, 12]:

Device (company)	De Novo	Granted	Regulation, product code	Later 510(k)s under that code, 2023 to 2025
reSET (Pear Therapeutics)	DEN160018	September 14, 2017	882.5801, PWE	0
ContaCT (Viz.ai)	DEN170073	February 13, 2018	892.2080, QAS	38
IDx-DR (IDx)	DEN180001	April 11, 2018	886.1100, PIB	2
Natural Cycles (Natural Cycles Nordic, Sweden)	DEN170052	August 10, 2018	884.5370, PYT	3
ECG App (Apple)	DEN180044	September 11, 2018	870.2345, QDA	5
EndeavorRx (Akili Interactive Labs)	DEN200026	June 15, 2020	882.5803, QFT	3

So check first whether a De Novo already created your device type. If it did, you may have a 510(k) predicate. Our comparison of 510(k), De Novo and PMA for SaMD covers the choice.

What does FDA expect in a SaMD 510(k)?

FDA expects three things: software documentation scaled to risk, cybersecurity information for connected software, and performance testing, which some regulations spell out [2, 6, 12]. Its premarket software guidance, issued June 14, 2023, sets two documentation levels: Basic and Enhanced [6].

Documentation level. Enhanced applies when a software failure or flaw could present a hazardous situation with a probable risk of death or serious injury [6]. You judge this before any risk controls. Basic applies to everything else [6]. FDA generally recommends Enhanced for Class III devices and combination products [6].

Documentation element	Basic	Enhanced
Level evaluation, software description, risk management file, requirements, architecture diagram, version history, unresolved anomalies	Submit	Submit
Software design specification	Keep in your records; FDA may ask for it	Submit
Development, configuration management and maintenance	Summaries, or a declaration of conformity to IEC 62304	Basic, plus complete configuration management and maintenance plans, or a declaration of conformity to IEC 62304
Software testing	System-level protocol and report, plus a summary of unit and integration testing	Adds unit and integration test protocols and reports

Our guide to FDA software documentation levels walks through the test.

Cybersecurity. Under section 524B, a "cyber device" includes software, can connect to the internet, and could be vulnerable to cybersecurity threats [2]. Its sponsor must submit a plan to monitor and address postmarket vulnerabilities and provide a software bill of materials (SBOM) [2]. The sponsor must also maintain processes that give reasonable assurance of cybersecurity, and make updates and patches available [2]. FDA updated its cybersecurity guidance on February 3, 2026 [7]. Our SaMD cybersecurity guide covers what to submit.

Performance evidence. Some regulations spell it out. For retinal diagnostic software, 21 CFR 886.1100 requires clinical performance testing of sensitivity, specificity and predictive values [12]. The special controls for over-the-counter ECG software and digital ADHD therapy also require clinical performance testing [12].

For clinical evaluation in general, FDA's CDS guidance points to the IMDRF document "Software as a Medical Device (SaMD): Clinical Evaluation" [3]. FDA's own guidance on the topic is no longer on its list of digital health guidances [10]. The IMDRF approach covers valid clinical association, analytical validation and clinical validation, as our SaMD clinical evidence guide explains.

You file the 510(k) as an eSTAR, which FDA requires for all 510(k) and De Novo submissions unless exempted [10].

You may already have software files from CE marking or IEC 62304 work. The hard part is knowing what FDA will still ask for. Complizen's free Gap Assessment compares your documents with what a 510(k) needs and names each missing item, with its cost and lead time.

Check FDA’s FY2027 guidance plans for software before you file. For AI software, see how FDA’s GMLP principles shape your evidence.

What did FDA clear for software devices in 2025?

FDA cleared 187 510(k)s in 2025 under product codes whose official names include "software", up from 109 in 2023 [9]. They took a median of 141 days from receipt to decision, against 126 days for all 510(k)s [9].

Year	510(k)s under "software" product codes	Share of all 510(k)s	From applicants outside the US	Median days, software	Median days, all 510(k)s
2023	109	3.3%	68	154	135
2024	145	4.7%	90	158	129
2025	187	5.8%	112	141	126

Radiology dominates. Product code QIH, automated radiological image processing software, had 94 of the 187 clearances in 2025. Triage software (QAS) had 15 [9].

Software 510(k)s took longer than the median 510(k) in each of the three years. These are past medians, not a promise for your device. In 2025, 21 of the 187 clearance letters also cleared a predetermined change control plan (PCCP) [9].

How we counted. We used openFDA 510(k) decisions of substantial equivalence, by calendar year. We kept product codes whose FDA device name contains "software". Review time is calendar days from FDA receipt to decision, including time spent answering FDA's questions [9]. This is a proxy, not an exact SaMD count. It misses codes such as LLZ, radiological image processing systems, with 58 clearances in 2025. It also includes a few hardware systems, such as a software-controlled endoscope holder.

For AI devices, our FDA AI device tracker breaks down all 1,614 by specialty, country and review time.

Do you need a new 510(k) when you update SaMD?

You need a new 510(k) when a change could significantly affect safety or effectiveness. A major change to the intended use also needs one (21 CFR 807.81(a)(3)) [12]. FDA's guidance on software changes, issued October 25, 2017, helps you decide case by case [8].

A PCCP lets you plan changes in advance. Under section 515C(b)(1) of the FD&C Act, a change consistent with a PCCP that FDA has cleared does not need a new 510(k) [8, 9]. FDA's final guidance on PCCPs for AI-enabled device software functions was last updated on August 18, 2025 [8].

PCCPs are still uncommon. In 2025, FDA cleared a PCCP with 85 of the 3,186 510(k)s whose documents we reviewed [9]. Our PCCP guide explains what goes into one.

If you plan regular model updates, read FDA’s PCCP examples before you file.

What does FDA charge for SaMD submissions in FY2027?

FDA's FY2027 fees apply from October 1, 2026 to September 30, 2027. A 510(k) costs $28,653, or $7,163 for a qualifying small business [11].

FDA fee (FY2027)	Standard	Small business
510(k)	$28,653	$7,163
De Novo request	$191,020	$47,755
PMA	$636,732	$159,183
513(g) request for classification	$8,596	$4,298
Annual establishment registration	$13,785	$13,785

For FY2027, FDA may waive the annual registration fee if paying would cause financial hardship [11]. The waiver is only for a business with $1 million or less in gross receipts or sales, including affiliates. It does not cover the initial registration [11]. Testing, cybersecurity work and any outside help are separate costs that depend on your device. Our fee calculator shows the fee for your submission type.

What do SaMD makers outside the US need to know?

Most 510(k)s under "software" product codes go to applicants outside the US: 270 of the 441 from 2023 to 2025 [9]. You follow the same 510(k) rules as a US company. Before commercial distribution, you also register, list your device and name a US Agent [12].

• Where clearances came from. From 2023 to 2025, France led non-US applicants with 38. South Korea and Israel had 34 each [9].
• US Agent. A foreign establishment names one US Agent when it registers. The agent must live or have a place of business in the US (21 CFR 807.40(b)) [12]. You do not need one to submit a 510(k) or to receive clearance.
• Timing. A device may not be imported or offered for import unless it is listed and made at a registered foreign establishment (21 CFR 807.40(c)) [12].
• Your home approval does not transfer. FDA decides on your evidence, though some test data may be reusable. Our guide to US Agent requirements covers the agent's duties.
• CE marking stays separate. Your IEC 62304 and ISO 14971 work can support both markets, but FDA expects its own documentation level and the eSTAR format [6, 10].

Which FDA guidance documents apply to SaMD?

Start with five: the 2022 software functions policy, the January 2026 CDS and general wellness guidances, the 2023 premarket software guidance and the February 2026 cybersecurity guidance [3, 4, 5, 6, 7]. These were the current versions on October 13, 2026:

Guidance	Status and date	Use it for
Policy for Device Software Functions and Mobile Medical Applications	Final, September 28, 2022 [5]	Which software functions FDA regulates
Clinical Decision Support Software	Final, January 29, 2026 [3]	Whether CDS is a device
General Wellness: Policy for Low Risk Devices	Final, January 6, 2026 [4]	Wellness apps and wearables
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices	Final, September 28, 2022 [10]	Software that only transfers, stores or displays device data
Multiple Function Device Products: Policy and Considerations	Final, July 2020 [10]	Products with device and non-device functions
Content of Premarket Submissions for Device Software Functions	Final, June 14, 2023 [6]	Software documentation in a submission
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions	Final, February 3, 2026 [7]	Cybersecurity and the SBOM
Deciding When to Submit a 510(k) for a Software Change to an Existing Device	Final, October 25, 2017 [8]	Changes after clearance
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions	Final, August 18, 2025 [8]	Planned AI model changes
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations	Draft, January 7, 2025 [10]	AI documentation, not yet final

What mistakes do SaMD makers make?

Most come from reading one rule in isolation. Check these four before you file:

1. Judging by platform. FDA looks at the software function, not whether it runs on a phone, a server or a scanner [5].
2. Stretching the CDS exclusion. Software that acquires, processes or analyzes images or signals, advises patients, or supports time-critical decisions does not qualify [3].
3. Letting wellness claims drift. Diagnostic thresholds, "clinical grade" claims or disease claims beyond the accepted wording can take a product out of the wellness policy [4].
4. Shipping model updates without a plan. A change that could significantly affect safety or effectiveness needs a new 510(k), unless a cleared PCCP covers it [8, 12].

Frequently asked questions

What does SaMD stand for?

SaMD stands for software as a medical device. It means software intended for one or more medical purposes that performs them without being part of a hardware medical device. FDA uses this IMDRF definition. Examples include software that detects disease in medical images and software that plans radiation treatment.

Is there an FDA list of cleared SaMD?

No single FDA list covers all SaMD. FDA's AI-enabled device list had 1,614 entries on September 4, 2026. But it covers AI devices only, includes some hardware and, FDA says, is not comprehensive. For other software, search FDA's 510(k) database by product code, such as QIH.

Is a mobile health app a medical device?

It is a device if its intended use is to diagnose, treat, mitigate, cure or prevent disease and no exclusion applies. FDA judges the function, not the platform. A fitness or sleep app with wellness claims only is usually outside FDA oversight. An app that detects atrial fibrillation is a device.

Is AI software always SaMD?

No. AI software is SaMD only if it has a medical purpose and works without being part of a hardware device. AI that is integral to a CT or MRI scanner is software in a medical device. AI used only for billing or scheduling is not a device at all under section 520(o).

Is clinical decision support software regulated by FDA?

It depends on four criteria in section 520(o)(1)(E). CDS for health care professionals is not a device if it meets all four. It must not acquire, process or analyze images or signals, and must show the basis for its recommendations. CDS for patients or for time-critical decisions remains a device.

Do I need a 510(k) for my SaMD?

You need one if your software is a device, no exemption or enforcement discretion policy covers it, and a legally marketed predicate exists. New low to moderate risk types use De Novo instead. Class III software needs PMA approval. Your classification regulation tells you which route applies.

How long does FDA take to clear SaMD?

There is no fixed time. In 2025, 510(k)s under "software" product codes took a median of 141 calendar days from receipt to decision. The median for all 510(k)s was 126 days. Your time depends on your submission and how fast you answer FDA's questions.

What does FDA charge for a SaMD 510(k)?

From October 1, 2026, FDA's 510(k) fee is $28,653, or $7,163 for a qualifying small business. A De Novo request costs $191,020, or $47,755 for a small business. Annual establishment registration is $13,785. Testing and other work are separate costs that depend on your device.

Do I need clinical data for a SaMD 510(k)?

It depends on your device type and claims. Some classification regulations require clinical performance testing, such as 21 CFR 886.1100 for retinal diagnostic software and 870.2345 for over-the-counter ECG software. Where no special control requires it, FDA decides based on your device, claims and predicate.

Can I update my SaMD after clearance without a new 510(k)?

Yes, if the change could not significantly affect safety or effectiveness and is not a major change to the intended use. FDA's 2017 software change guidance helps you decide. Changes consistent with a cleared PCCP also do not need a new 510(k). In 2025, 85 of 3,186 510(k)s we reviewed included one.

Is there a SaMD certification?

No. FDA does not certify software. It clears 510(k)s, grants De Novo requests and approves PMAs. You also register your establishment and list your device, but 21 CFR 807.39 says registration does not mean FDA approval. Other markets, such as the EU, run their own systems.

Do non-US SaMD companies need a US Agent?

Yes. A foreign establishment must name one US Agent when it registers with FDA, under 21 CFR 807.40(b). You do not need a US Agent to submit a 510(k) or receive clearance. You need registration, listing and a US Agent before commercial distribution in the US.

References

1. FDA. Software as a Medical Device (SaMD), content current as of December 4, 2018, and What are examples of Software as a Medical Device?, content current as of December 6, 2017.
2. Federal Food, Drug, and Cosmetic Act, section 520(o), 21 U.S.C. 360j(o), and section 524B, 21 U.S.C. 360n-2. U.S. Code, 2024 edition.
3. FDA. Clinical Decision Support Software. Final guidance, January 29, 2026.
4. FDA. General Wellness: Policy for Low Risk Devices. Final guidance, January 6, 2026.
5. FDA. Policy for Device Software Functions and Mobile Medical Applications. Final guidance, September 28, 2022.
6. FDA. Content of Premarket Submissions for Device Software Functions. Final guidance, June 14, 2023, with FDA's QMSR preface.
7. FDA. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. Final guidance, February 3, 2026.
8. FDA. Deciding When to Submit a 510(k) for a Software Change to an Existing Device, final guidance, October 25, 2017, and Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, final guidance, updated August 18, 2025.
9. FDA data: De Novo Classification Request page and De Novo database records DEN160018, DEN170052, DEN170073, DEN180001, DEN180044 and DEN200026; Artificial Intelligence-Enabled Medical Devices list, current as of September 4, 2026; and openFDA 510(k) API decisions from 2023 to 2025, with 2025 clearance letters and summaries, analyzed by Complizen. Accessed October 13, 2026.
10. FDA. Guidances with Digital Health Content, content current as of April 9, 2026; Multiple Function Device Products: Policy and Considerations, July 2020; and eSTAR Program, content current as of September 21, 2026.
11. FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
12. eCFR. 21 CFR 807.20, 807.22, 807.39, 807.40 and 807.81, and classification regulations 870.2345, 882.5801, 882.5803, 884.5370, 886.1100, 892.2050 and 892.2080. Text checked in the April 1, 2025 annual edition via govinfo.