Everything You Need to Know About Medical Device Compliance

Credit: Marcel Scholte


Medical device companies play a huge role in public health. So it’s little wonder that governments, NGOs, investors, and consumers hold the industry to such rigorous standards.

In fact, every step of a medical device’s journey to market is tightly regulated, from the manufacture and marketing of the product itself, to corporate responsibility and vendor management.

In the United States, the Food and Drug Administration (FDA) is tasked with developing, overseeing, and enforcing regulatory compliance among all products that potentially pose a risk to public health.

This includes foods, drugs, veterinary products, tobacco, electronics that produce radiation, cosmetics, and, of course, medical devices. In this article, we take a tour of the FDA’s approach to medical device compliance.


Fundamentals of Medical Device Regulations

At its heart, regulatory compliance is all about ensuring the safety, efficacy, and reliability of medical device products. In the pursuit of creating fair and rigorous protocols for a variety of product categories, the FDA has developed multiple approval pathways. Without FDA approval, a medical device cannot legally go to market.

Before deciding on which pathway to take, you must determine which of the three classes your medical device falls into. This is largely based on its risk profile and similarity to existing products.


Class I

Class 1 includes medical device products that pose the lowest risk to public health and safety. For example, an electric toothbrush, oxygen mask, tongue depressor, and bandages are all considered Class 1 medical devices.


Class II

Class 2 products pose a moderate level of risk to public health and safety. Therefore, these products require some degree of risk regulation. Examples of Class 2 devices include pregnancy test kits, blood pressure cuffs, blood transfusion kits, and syringes.


Class III

Class 3 medical devices are described as the most risky and require regulatory control. For instance, defibrillators, pacemakers, breast implants, and implanted prosthetics are all categorized as Class 3 products.



Regulatory Pathways for Medical Device Classes

Bringing a medical device to market is a rigorous journey through medical compliance. Though the pathway varies depending on the device class, the aim is to ensure the safety, reliability, and efficacy of a product before it goes to market. Let’s look at three of the seven pathways.


Premarket Notification (PMN)

Premarket Notification (PMN), otherwise known as 510(k) clearances, pertains to all Class 1 and certain Class 2 medical devices.

To qualify, these devices must be substantially equivalent to a product that already legally exists in the US market (since May 28, 1976 or later). You must demonstrate that your predicate device has (1) the same intended use and (2) similar technology to the comparison one. This also allows you to source previous data to support your own product.

Obtaining PMN status allows new versions of medical devices to sidestep the approval or clearance process and go straight to market. Nevertheless, devices must still be registered with the FDA and review can take up to 90 days. Class 2 devices with 510(k) clearances include X-ray machines, dialysis machines, and fetal monitors.

If approved, your device will be granted the same class number as the previous device. If denied, your device is considered Class 3 and you must apply for Premarket Approval (PMA).

Medical Device Compliance

Credit: Myriam Zilles


Premarket Approval (PMA)

Premarket Approval (PMA) is the most rigorous FDA review process for medical devices. This pathway is largely used to determine the uniqueness, safety, and efficacy of Class 3 medical devices.

First, the FDA must decide whether the potential benefits of a particular Class 3 product outweigh the potential risks associated with it. Additionally, the manufacturer must provide evidence that the device will be useful to a sizable percentage of its target market. The review process takes between 180 and 320 days.


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Humanitarian Device Exemption (HDE)

Humanitarian Device Exemption (HDE) is the rarest compliance pathway. This pathway is reserved for medical devices that address orphan diseases.

An orphan disease is a rare disease that has an incidence of 200,000 national cases or less. Today, there are an estimated 7,000 orphan diseases, only a small portion of which has approved treatments.

Because the illness is comparatively rare, medical literature and patient data are sparse. Therefore, the HDE pathway enables companies to develop medical devices to treat these rare conditions, without requiring the big scientific review common to other pathways.

To apply for this pathway, you must not prove that no other device currently exists to treat the illness. The review process for HDE lasts approximately 75 days. If accepted, the product is granted Humanitarian Use Device (HUD) status.

The design and manufacturing of medical devices can follow four other pathways, as well. This includes the Expanded Access Program (EAP), Custom Device Exemption (CDE), Product Development Protocol (PDP), and De Novo.


What is the Safe Medical Device Act?

In November of 1991, the federal law known as the Safe Medical Device Act (SMDA) came into effect. SMDA aims to safeguard the public by ensuring that medical devices are not  unsafe when used appropriately.

The law mandates that any organization using medical devices must report serious injuries, illnesses, or deaths that result, or are suspected to have resulted, from the device in question. These reports should be presented to the FDA and the medical device manufacturing company responsible for the product.


Is FDA Regulatory Compliance Recognized Internationally?

Compliance paths differ from one region to the next. For instance, while the US follows the FDA guidelines outlined in this article, the European medical device industry adheres to the EU regulations.


RBC and Medical Device Regulatory Compliance

When it comes to medical device compliance in the US, we’re really just scratching the surface. The FDA website can answer any outstanding questions you may have.

At RBC Medical, we’ve been designing and manufacturing medical devices for over 25 years. By adhering to and exceeding FDA compliance regulations, we’ve been able to reduce risks, optimize efficacy, improve reliability, and get our products to market faster. Contact us today to discuss how we can get your medical device to market.



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