FDA Regulatory Requirements for New Medical Devices

Published on by John Teel

So you have a great idea for a device to diagnose or treat a disease or medical condition. First, you need to figure out if it is a “Medical Device” as defined by the US Federal Government.

The term “Medical Devices” can include anything from a tongue depressor to an MRI machine. There’s a wide range of complexity amongst all the products that are regulated under the rules of the US Food and Drug Administration (FDA).

FDA rules have a big impact on how you do things, so it’s important to know if they apply to you. The rules the FDA enforces are intended to ensure that Medical Devices marketed in the US are both “safe” and “effective”.

NOTE: This is a long, very detailed article so here's a free PDF version of it for easy reading and future reference.

This is a guest article by Bruce Christie of BAC Engineering. Bruce has 40 years of experience in the design and manufacture of a wide range of products from medical implants to consumer electronics, but with a special emphasis on medical devices.

To the FDA, “safe” means no harm comes to the user, patient, or others during use.

“Effective” means that the device is very likely to accomplish its medical purpose when used.

This post is intended to help you determine if your product is regulated by the FDA, and if so, what sort of regulations would apply.

The FDA Legal Definition

There is a specific definition in the law that delineates the scope of regulated Medical Device products.

From section 201(h) of the Food, Drug, and Cosmetic Act:

“a [medical] device is:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

The reference to chemistry in clause 3 doesn’t mean such things aren’t regulated, just that they will fall under the “Drug” section of the Act.

Also, the exception about software only relates to products exclusively used for administration, lifestyle advice, or electronic health records (with NO analysis).

Anything else that is used for “diagnosis, cure, mitigation, treatment, or prevention of disease”, or that “affects the structure or any function of the body” will fall within the legal definition of a Medical Device.

As long as it’s not a drug, your medical product idea will probably be defined as a medical device. You can visit the FDA’s page for more specifics.

Similar regulations exist in other countries. If your product is defined as a Medical Device in the US, chances are it will be defined that way in other locations. If you plan on selling your product internationally then additional rules will apply.

Lifestyle Products

It is still possible that your idea will not be classified as a Medical Device, especially if it falls under the “lifestyle” category. This category includes products like a pedometer, which can count your steps and help you raise your activity level.

Your product would not fall under the lifestyle category if it diagnoses something. For example, a pedometer that recognizes a pathological gait. A lifestyle product cannot claim to “treat” in even a vague way, or claim to do something medical.

For example, a colored lamp that is supposed to “exert a calming influence” would not be a Medical Device. But if you claim it “treats depression”, the FDA will deem it a Medical Device and insist that you prove it both safe and effective.

Software-Only Products

What about software-only products? A Medical Device can definitely be software-only. Examples include programs that analyze scans for signs of tumors, or software that properly calculates the power of an intraocular lens for a cataract patient.

On the other hand, a menu planner/calorie counting app that helps you lose weight would not be classified as a Medical Device.

Medical Device Classifications

It’s important to understand that the regulation of medical devices is predicated on risk management. Risk management in this context means identification, analysis, mitigation, and evaluation of any hazards to the patient, user, or others in the use of the device.

The FDA divides low to high risk into three levels, called Classes I, II, and III. Different levels of regulation apply to each. You can read the FDA’s details about these regulations here.

A lot depends on whether your idea is truly novel or more of a “better mousetrap” idea. If it’s the latter, you can find products very similar to yours in the FDA’s “classification panels” broken down by medical specialty.

A lot of specific rules and standards will probably apply, and you can conclude that your device will be classified the same way.

If you can’t find something like your own device in the panels, or if you use a different technology, or if your indications and contraindications are different, then you may have more work to do.

This is because the risks of pre-existing devices are well known, and you can rely on that by showing that your device is “substantially equivalent” to its “predicate device” (except for high-risk devices).

This process is generally easier than managing the risks of a truly novel device.

Occasionally, there can be more than one predicate device for your product to reference. An example would be an endoscope with an added biopsy probe, that references two prior devices.

If there is no predicate for your device, or parts of it, then you will have to show that your design and manufacturing are safe and effective.

So the tests you perform are more rooted in actual use, and you have to justify your choice of tests and acceptance criteria.

With a predicate, you may be able to get away with comparing the technical performance of your device to the predicate in lab conditions using test methods in recognized standards (ISO, ANSI, IEC, etc.).

The following sections below describe the classifications in more detail.

Knowing which Class your device falls under is very important, because the expenditures of time and cost to get to market are very different by Class. Let’s look at the classifications in more detail.

Class I Medical Devices

Some Medical Devices carry few risks of use. Such devices are called Class I, and are defined as:

“Devices not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”

So bandages, beds, bedpans, oxygen masks, stethoscopes, eye charts, scales, and thermometers all fall under this Class, as long as they don’t venture into diagnosis (like a digital stethoscope that recognizes arrhythmias).

Class I devices are “non-invasive”, meaning that they typically do not enter the body but may be applied to it (like a splint).

If you’re lucky enough to have a Class I idea, then only the so-called “General Controls” apply to your operations. For more info you can see Title 21 of the Code of Federal Regulations, Section 820: the Quality System Regulation.

General Controls include:

  • Adulteration – cleanliness and purity, but also “failure to meet performance standards”
  • Misbranding – proper labeling of identity, specs, etc.
  • False or Misleading Labeling – unsubstantiated claims, etc.
  • Establishment Registration Requirements – getting your facility approved
  • Device Listing Requirements – telling FDA about your device characteristics
  • Premarket Notification Requirements – telling FDA you’ll be selling in the US
  • Banned Devices – if you find your device here, it’s not a good thing…
  • Notification and Other Remedies – adverse event reporting, etc.
  • Records and Reports on Devices – information on manufacturer testing and use
  • Restricted Devices – governs what you can say when promoting your product
  • Quality System Regulation, Good Manufacturing Practices – rules that apply to manufacturer

General Controls aren’t quite as scary as they sound, and there are plenty of partners who can supply the compliance you need in both development and manufacturing.

The regulations are pretty clear, and the FDA will help if you reach out. But do understand that you are still responsible for the safety and efficacy of the device you sell, even if it’s your contract manufacturer that screws up.

The FDA can shut you down if you fail in this duty. Class I devices may be marketed without prior permission, but you are required to notify FDA beforehand.

Class II Medical Devices

Lots of products fall under Class II. Most diagnostic instruments fall under Class II – they may be safe to use (so they’re not Class III), but if they give false information patients could be harmed (so they can’t be Class I).

Many surgical devices are Class II, if they are unlikely to seriously harm the patient and are not life supporting (like a ventilator or aneurysm stent). A lot of stuff that gets used at a specialist’s office falls under Class II.

Class II products may be invasive for short term use (like a surgical instrument), but they do not include long-term, implantable products (like an artificial pancreas).

With Class II devices, the FDA’s “special controls” also apply. These include:

  • Performance standards – usually ISO standards for specific kinds of devices
  • Post market surveillance – the responsibility to look for and report problems in the field
  • Patient registries – the responsibility to collect clinical data on device performance
  • Special labeling requirements – generally for in-vitro diagnostics
  • Premarket data requirements – stuff you must submit to FDA:
    • Intended use specifications and validation
    • Human factors/usability engineering
    • Simulated use analysis
    • Hazard and traceability analysis
    • Pre-analytical, analytical, and clinical studies
    • Adverse event documentation for clinical/non-clinical use
    • Specific controls related to IEC, ISO, and other standards
    • Specific/explicit testing
    • Operation/maintenance instructions and labeling
    • Guidelines – specific requirements for particular device types

Clearly, special controls add a lot of work. Premarket data is very detailed and rigidly formatted. Everything must be documented, and you must be able to demonstrate that all of the applicable requirements have been met with objective evidence.

This is not work for the inexperienced, and if you get it wrong you can suffer long delays when your submission is not accepted.

Class III Medical Devices

Class III is reserved for the highest risk devices. Failure or misuse of Class III devices may kill or seriously injure a patient or user. Examples include heart-lung machines, heart valves, radiation therapy devices, and joint replacements.

In addition to general and special controls, Class III devices are subject to Premarket Approval. This means that you have to submit your premarket data to the FDA and wait for an explicit approval before you can begin selling in the US.

Often times, premarket data must include design validation by controlled clinical trials. Clinical trials may have to enroll hundreds or thousands of patients, who may have to be followed for several years before the study may be submitted.

As you may imagine, this can get expensive. Like with development and manufacturing, expertise is extremely important.

You can contract out your clinical trials to a clinical research organization, but be sure you have medical professionals (doctors, nurses, techs) on your team to oversee the trials and their results.

The Bottom Line

There are a lot of extra things to deal with if your product idea is a medical device. Unlike consumer device development, there is testing involved to get a product approved, and you become open to extra scrutiny on how you run your business.

You have to develop and maintain good relations with regulators and put up with things like on-site inspections. There will definitely be more paperwork.

Few entrepreneurs are prepared to deal with this highly-choreographed dance. If you don’t have experience in the Medical Device business, seriously consider getting a partner who does or find an expert to help guide you.

Also, consider approaching a contract manufacturer rather than building things in your garage once you’re past your prototype stage. This will help you avoid unnecessary delays such as insufficient test data requiring full retesting.

Get a medical device approved sounds like a lot of headaches, right? Don’t get down, fortunately there are plenty of people who can help, and startups get new and novel products approved every year.

The rules you need to follow are well-documented and pretty rational. And if you succeed, there’s nothing much more rewarding in life than helping patients who really need it.

Need expert guidance getting your new medical product to market? If so, get the expert help you need inside the Hardware Academy starting at only $49/month.

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