Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working on a product that will serve the public health and help a select group of people better manage a health condition or procedure that would otherwise make their lives more difficult.
But, as you add features, your product changes. At one point in time, your product might have promoted general wellness.
That latest feature you implemented, however, may have shifted it across the line into medical device territory. Don’t fret! But do understand and familiarize yourself with the medical device industry you’re now entering. This guide is for you.
What is a medical device?
It’s difficult to determine what is and isn’t a medical device, or when something becomes or stops being a medical device.
Take a Popsicle stick. Wrap 100 Popsicle sticks individually and put them for sale in a craft store, and they’re still Popsicle sticks. They need not follow any guidelines.
But put those same, or similar, individually wrapped Popsicle sticks in a medical catalog and instruct physicians to use them as tongue depressors and they become medical devices that require strict adherence to regulatory requirements for compliance.
This shift from product to medical device can be confusing for some, especially as products get enormously more complex than tongue depressors. Normal product development decisions, such as adding new features or pursuing a new market, can mean encountering an entirely new regulatory regimen.
Medical Device Definition
A simple medical device definition is hard to come by because so many products can theoretically be medical devices. Medical devices include simple tools like tongue depressors, complex machinery like artificial hearts, and non-physical devices like medical software.
In the United States, the relevant market for this guide, the question of what is a medical device is answered by the Food and Drug Administration (FDA).
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- 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
- 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
Put simply: a medical device is a product that fulfills that FDA definition.
Put even more simply, a medical device is a product that diagnoses, treats, or prevents disease by affecting the structure or function of the body.
Challenges with defining Medical devices
The lines around the definition of a medical device are blurry and require multiple bullet points because medical devices can brush up closely against pharmaceuticals.
While pharmaceuticals achieve their primary intended purpose through chemical action, medical devices do not. However, many products that don’t achieve their primary intended purpose through chemical action also aren’t medical devices.
Try looking for factors that will shift how your product is classified. If you add a new feature that affects the structure or function of the bodies of your users, that might mean your product requires a new classification. That new feature means your product is now a medical device.
A new market that involves a different user base might also regulate classification differently from a different region of the world. If you determine your product will be used by healthcare providers, rather than patients, in a diagnostic or treatment setting, this decision will influence the classification of your device.
When does a product become a medical device?
In the United States, a product becomes a medical device once it fulfills FDA's definition of a medical device. A product that might be a medical device becomes one when the feature set evolves enough so that it can adequately be described as a medical device under that definition.
That’s a simple answer to a complex web of hard-to-determine, borderline-medical-device products—some of which are not medical devices and then, with the roll out of a new feature, becomes a medical device.
This complexity isn’t the result of regulation run amok. FDA takes a risk-focused approach to its regulations, and as a result of that philosophy, makes classification an essential first principle.
FDA determines what constitutes a medical device
FDA oversees medical devices and a broad range of other federally mandated industries in the United States. The Center for Devices and Radiological Health (CDRH) is the specific branch that controls medical devices.
If your product doesn’t appear to be a medical device, there are other FDA Centers that may be more applicable, such as:
Center for Tobacco (CTP)
If your device is a medical device, the CDRH will be the office you report to for all of your regulatory needs.
The mission of the CDRH is to promote and protect public health. This follows through with its regulatory approach to classifying devices based on the perceived risk of the product type.
If you imagine every regulation or industry standard on a flowchart, classification is the first branch. All other requirements, from a regulatory standpoint, will stem from the class determination, such as your medical device risk management.
I cannot stress enough how important it is to establish good risk management practices early on. In fact, some of the best QMS software tools come with built-in risk management workflows that follow industry best practices of ISO 14971, the international standard for risk management of medical devices.
Product classification is easier said than done. While determining the class of high-risk products like catheters and heart rate monitors may seem like a straight-forward, easy call to make, there are plenty of products that require a much deeper analysis in order to ascertain classification.
Some product types that often get wrongly labeled as medical devices are:
- Borderline products
- Software products
- General wellness products
- Combination products
Let’s talk about each one in a bit more detail to clear up some of the confusion.
Borderline products: Borderline products sit between device and drug classifications, which make them harder to classify. Examples include beta blockers (a drug) and topical surgical adhesive (a device).
Software products: Mobile and web-based applications often defy assumptions about classifications. They lack the hardware that would typically make you think of them as “devices,” but there’s another sub-category — software as a medical device — that an application might fall under that comes with its own set of regulatory requirements.
General wellness products: There are many low-risk products that “promote a healthy lifestyle” but don’t necessitate FDA oversight. These products are deemed general wellness and don’t fall under medical device regulations. A product that plays soothing music to aid stress management, for instance, is low-risk enough that it would be designated as general wellness.
Combination products: Some products combine combine device and drug features. These are especially hard to classify. Examples, as FDA cites, include a monoclonal antibody combined with a therapeutic drug, a drug or vaccine vial packaged with a delivery device, and a first-aid kit containing devices and drugs.
medical device classifications
FDA will classify your device as one of the following three types: Class I, Class II, and Class III. Broadly speaking, medical device classification is based on the perceived risk of of a product. This is the framework your device will fit into.
Classifications in the US range from Class I medical devices, which are relatively low-risk, to Class II medical devices, which pose moderate risk, and Class III medical devices, which are relatively high-risk. The higher the number, the more regulatory controls are necessary to provide reasonable assurance of the safety and effectiveness of the medical device.
Class I medical devices: General Controls
All medical devices require general controls except for ones that qualify for a special exemption.
General controls are broad and wide-ranging, carrying their own set of requirements which can be found in the following sections of the FD&C Act:
- 501: Adulterated devices
- 502: Misbranded devices
- 510: Registration of producers of devices
- 516: Banned devices
- 518: Notifications and other remedies
- 519: Records and reports on devices
- 520: General provisions respecting control of devices intended for human use
Class II medical devices: General Controls and Special Controls
FDA considers general controls necessary, but not sufficient for controlling these kinds of devices, so class II medical devices require additional controls known as "special controls". These special controls are specific to each device and based on the context of a particular device.
FDA cites this list of special controls which may include:
- Performance standards
- Postmarket surveillance
- Patient registries
- Special labeling requirements
- Premarket data requirements
Before you can legally market Class II devices, FDA also requires a premarket notification, also known as a 510(k) submission. 510(k) clearance from FDA demonstrates that the submitted device is “substantially equivalent” to a predicate device that’s already been legally marketed in the US.
Class II medical devices include products like pregnancy tests, sutures, and powered wheelchairs, all of which pose moderate risks.
Class III medical devices: General Controls and Premarket Approval (PMA)
Class III medical devices, the highest risk classification, are, according to FDA, those that are “intended to be used in supporting or sustaining human life or preventing impairment of human health.” Class III also includes any device that presents a risk that general or special controls cannot cover.
All Class III devices are subject to premarket approval by FDA. Premarket approval requires scientific evidence, often in the form of a clinical trial, to prove that your device will be safe and effective for end users.
Examples of a Class III device include implantable devices, such as a pacemaker or blood vessel stent.
FDA's recommendation for determining device class
FDA provides the classification framework, but it’s up to you to make sure your company is prepared for the classification you’re going to receive.
If you assume your product is Class I and it’s actually Class II, it’s going to be costly to redraw all of your plans and add the necessary controls FDA requires for compliance.
The sooner you have an expected classification in mind, the sooner you can initiate design and development activities, such as design controls and risk management, and begin to implement your go-to-market strategy.
You can follow this three-step process, recommended by FDA, to help you determine whether your product will be regulated by the FDA as a medical device:
- Define intended use and indications for use.
Intended use is what your product is used for; indications of use describe the contexts and reasons for usage. As your product evolves, clear and simple statements of these definitions will help guide you.
- Determine definition-fit.
Does your product meet the definition of a medical device according to Section 201(h) of the Food, Drug & Cosmetic Act?
To find this answer, use the intended use and indications for use you determined in step one. With those in hand, you can see if your product meets the definition.
- Determine if a product classification exists for your product.
If your product does meet the above definition, is there an appropriate product classification for your device?
To figure that out, find precedent in one of the FDA databases. You can use the FDA Product Classification Database or search for similar devices on the Establishment Registration & Device Listing database.
Welcome to the medical device club
After understanding how you can determine if you have a medical device and the next steps you should take if so, you’ll be ready to make the switch to True Quality.
True Quality is the highest level of standard to which medical device professionals, processes, and technologies are measured and serves as the driving force for the industry’s shared mission to improve and save lives.
By making the switch to True Quality, you can eliminate the status quo of treating compliance as a checkbox activity and position your company as a medical device leader.
We strongly recommend considering a reenlight Guru offers the industry’s only medical device QMS (MDQMS) software designed from the ground up to take new medical devices, such as yours, from initial concept to market success.
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