When Does Software Become A Medical Device?
When does software become a medical device? In some cases, it’s clear-cut. If your software is used to diagnose or treat patients, then it’s a medical device. But what…
[SERVICE]FDA regulatory
FDA regulatory compliance for medical devices and software
FDA counsel for medical device, medical software and wearable companies, from the premarket pathway to quality systems and post-market duties, planned alongside your patents.
[01]Who it's for
For companies bringing a medical product to market.
FDA compliance decides when you can sell in the US, and investors look at the regulatory plan as closely as the patents. Getting the pathway right early avoids delays, recalls and redesigns later.
Medical device startups
A first device headed for 510(k), De Novo or PMA review, with a plan investors can follow.
Software as a medical device
Apps, algorithms and AI that inform a diagnosis or treatment decision.
Wearables
Devices that sit between consumer electronics and medical regulation.
Established device makers
Registration, quality system and post-market obligations as the product line grows.
Industries we work in
[02]What we handle
From pathway to post-market.
The firm’s FDA regulatory compliance work covers the whole life of a device. We do not promise clearance or approval, and no one honestly can.
Regulatory filings and patents run on separate clocks. We plan both so the patent application is on file before anything becomes public.
What we help with
- Premarket submission strategyChoosing and preparing a 510(k), De Novo or PMA submission, including clinical trial strategy and answers to FDA requests for more information.
- SaMD and wearablesClassification, software validation and documentation, cybersecurity and interoperability.
- Registration and listingInitial establishment registration, annual renewals and device listing updates, including foreign establishments.
- Quality system and post-marketGap analysis, quality documentation, inspection preparation, complaint handling, reporting and recalls.
Gaps we look for
- A device in the wrong classWhich sets the wrong pathway, timeline and budget.
- A predicate that does not fitA 510(k) built on a device that is not substantially equivalent.
- Design controls added lateDocumentation reconstructed after the design is done.
- Disclosure before the patentA public submission, trial listing or demo before the invention is filed.
[03]How it works
How FDA regulates medical devices.
FDA regulatory compliance for a medical device starts with its classification. FDA sorts devices into three classes by risk, and the class largely decides which premarket pathway applies and how much evidence the agency expects.
| Class | Risk | Usual pathway |
|---|---|---|
| Class I | Low, such as many hand tools and bandages | Most are exempt from premarket notification but still follow general controls |
| Class II | Moderate, such as many monitors, pumps and diagnostic software | Most need a 510(k) |
| Class III | High, such as implants that sustain life | Generally premarket approval (PMA) |
510(k), De Novo or PMA
| Pathway | When it fits | What it shows |
|---|---|---|
| 510(k) premarket notification | A similar legally marketed device (a predicate) exists | Substantial equivalence to the predicate |
| De Novo request | A novel device of low to moderate risk with no predicate | Reasonable assurance of safety and effectiveness, and a new classification |
| Premarket approval (PMA) | A high-risk Class III device | Safety and effectiveness, usually with clinical data |
For a 510(k), choosing the predicate is the central decision, and the submission argues equivalence to it. For a De Novo, the submission has to show the device is safe and effective on its own. A PMA usually needs clinical trial data, so the trial design matters as much as the filing.
Medical device startups also have to time patents against these filings. Read IP and FDA regulatory strategies often go hand in hand, and see our medical device patent page.
[04]Software and wearables
Software as a medical device and wearables.
Software can be a medical device on its own, with no hardware at all. Whether it is depends on its intended use, the claims you make about it, not on the code.
Is your software a medical device?
Software intended to diagnose, treat, cure, mitigate or prevent a disease is generally a device. Since the 21st Century Cures Act of 2016, some software functions are excluded, such as administrative tools, general wellness apps, electronic health records and certain clinical decision support that lets a clinician independently review the basis for a recommendation. More on when software becomes a medical device.
What we help SaMD companies with
- Classification. Determining the regulatory classification from the intended use and risk level.
- Validation and documentation. Guidance on software validation and the documentation FDA expects.
- Cybersecurity and interoperability. Devices that connect to the internet and meet the definition of a cyber device have to include cybersecurity information in premarket submissions under section 524B of the FD&C Act, in effect since March 2023.
- Digital health guidance. Keeping the product in line with FDA’s current guidance on digital health technologies.
Wearables
Wearables sit where consumer electronics meet device regulation. The firm’s work here covers usability outside a clinic, data privacy and security, integration with mobile health platforms and electronic health records, and continuous monitoring and data management. Patient data also raises the questions on our privacy and data protection page.
[05]Registration, quality and post-market
What FDA expects after the submission.
Compliance does not end with clearance or approval. Three sets of obligations follow the device for its whole life.
Establishment registration and device listing
Establishments that make or distribute devices for the US generally register with FDA and list their devices, and renew each year between October 1 and December 31. Foreign establishments also name a US agent. We help determine what your business activities require, prepare initial registrations and annual renewals, and keep device listings current.
Quality management system
FDA’s quality system rule is now the Quality Management System Regulation (QMSR). Since February 2, 2026, it incorporates the international standard ISO 13485:2016. The firm’s work includes gap analysis of an existing quality system, quality manual, procedures and forms, guidance on design controls, process validation and risk management, and preparation for FDA inspections, including mock audits.
Post-market surveillance
After launch, manufacturers handle complaints, report certain adverse events to FDA through Medical Device Reporting, and manage corrections and recalls. We help build complaint handling and reporting systems, plan post-market clinical follow-up studies, assist with recalls and field safety corrective actions, and set up monitoring of real-world performance for SaMD and wearables.
[06]Fees
One flat fee, quoted before work begins.
There is no hourly billing. Your FDA regulatory work is quoted as a flat fee on your strategy call, once the scope is clear, and nothing starts until you approve it.
Book A Free Strategy CallWhat sets the fee is the work itself, not the time on the clock.
- The device and its class. A Class I listing is a different job from a PMA.
- The deliverable. A pathway strategy, a submission, a registration, a quality system review or post-market support.
- What already exists. Testing, documentation and quality records you have in place.
Ongoing work for a growing company can run on a monthly Fractional IP Counsel plan instead of one fee per document. This service is not covered by The RLG Guarantee, which applies to patentability searches, provisional patents, design patents and trademarks.
[07]The process
From first call to a regulatory plan.
What happens at each step and who does the work. FDA review times are set by the agency and are never a promised date.
FDA regulatoryCall to plan
- Day one01Day oneStrategy callFree. Walk us through the deal, the documents or the problem.
- Flat fee02Flat feeScope and flat feeWhat the work covers and its price, in writing, before it begins.
- 03Classification and pathwayIntended use, class and the pathway that fits.
- 04Documents and submissionWe prepare or review what FDA will see, with you approving it.
- 05Ongoing complianceRegistration, quality system and post-market duties as you grow.
[08]Questions
Questions about FDA regulatory compliance.
Still deciding? Your first call is free and comes with a straight answer on where your device stands.
Book A Free Strategy CallWhat does FDA regulatory compliance mean for a medical device?
Meeting FDA’s requirements to market and keep selling a device in the US. That includes the right premarket pathway, establishment registration and device listing, a quality management system, labeling, and post-market duties such as complaint handling, adverse event reporting and recalls.
Is my software a medical device?
It depends on its intended use. Software meant to diagnose, treat, mitigate or prevent disease is generally a device, even without hardware. Some functions, such as general wellness apps, administrative tools and certain clinical decision support, are excluded. Classification is the first thing we look at on your call.
What is the difference between a 510(k), De Novo and PMA?
A 510(k) shows your device is substantially equivalent to a legally marketed predicate. A De Novo request is for a novel low to moderate risk device with no predicate. A PMA is for high-risk Class III devices and usually needs clinical data.
Do I need to register with FDA?
Most establishments that make or distribute devices for the US must register and list their devices, and renew every year between October 1 and December 31. Foreign establishments also name a US agent. Some activities are exempt, which we check for you.
What is the QMSR?
The Quality Management System Regulation, FDA’s updated quality rule for device makers. Since February 2, 2026, it incorporates ISO 13485:2016, so companies built around the old Quality System Regulation may need to update their procedures.
Can you guarantee FDA clearance or approval?
No. FDA decides, and no one can honestly promise an outcome. What we can do is help choose the right pathway, prepare a complete submission and respond to the agency’s questions.
Should I file a patent before my FDA submission?
Usually, yes. A De Novo or PMA decision summary, a clinical trial listing or a public demo can disclose the invention. Filing the patent application first, often as a provisional, protects it before anything becomes public.
How much does FDA regulatory compliance work cost?
With us it is a flat fee, quoted on your strategy call before any work begins. It depends on the device, its class, the deliverable and what documentation already exists. FDA’s own user fees are separate and set by the agency.
[09]Learning Center
Go deeper on MedTech and FDA.
IP and FDA Regulatory Strategies Often Go Hand-In-Hand
In the medical device industry, it is common for medical device companies to seek regulatory approval on new medical devices and innovations from the Food and Drug…
How IP Assets Can Help Med Device Startups Raise VC Funding
Have you ever heard the expression, “you have got to spend money to make money?” It is often a necessity in entrepreneurship to invest in yourself in order to get others…
[10]Client reviews
Founders who built with us.
4.7 across 614 public reviews on Google, Trustpilot and Avvo.
#1Top reviewed IP law firm*
Read client reviews“The Rapacke Group stands by their fees with no surprises.”
Lowell CrawfordClient review “From creating a new business and checking to make sure we were in full compliance, the team at The Rapacke Law Group handled everything with ease for us.”
Aqua Fire PitBusiness formation · Client review “I always felt confident that my intellectual property was in good hands.”
JakePatent · Client review
Reviews reflect individual client experiences. Quotes are excerpts. Prior results do not guarantee a similar outcome. *#1 top reviewed means the most public client reviews on Google, Trustpilot and Avvo of any US patent or trademark firm.
Plan the path to market.
Talk through your device, its intended use and your timeline. The call is free, with no obligation.