If you are a drug manufacturer moving into the medical device space or even a new firm specializing solely in devices, it helps to be aware of how medical device clinical trials are conducted. There are a few key differences between the two.

Medical device trials are handled by the Center for Devices and Radiological Health while drug and biologic trials fall under CDER and CBER respectively. The FDA website includes an excellent presentation from CDRH outlining the process and how device clinical trials diverge from drug clinical trials. 

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Device Trials: 4 Differences

Medical device clinical trials differ from drug clinical trials in the following four aspects:

  1. Subjects who participate
  2. Who administers drugs versus devices
  3. Training requirements
  4. Overall FDA approval process

First, device trials tend to be smaller than drug trials. Physician technique plays a larger role than in pharmaceuticals. Modifications to the device in question may even occur during the trial. Endpoints can be highly diverse.

In general, medical device clinical trials begin with a feasibility study which is a limited clinical evaluation of the device. Following this stage, a pivotal trial is conducted to demonstrate the device in question is safe and effective for a specific use within a distinct patient population follows feasibility stages. 

And device trials serve to support “a reasonable assurance of safety and effectiveness” within the marketing application. In a broader sense, device trials can be considered to have three stages: feasibility study, pivotal study to determine if the device is safe and effective, and post-market study to analyze the long-term effectiveness of the device.

Device trials tend to be smaller than drug trials

Keep in mind, this is for the U.S. FDA—of course, medical device regulations differ among global regulatory agencies. A future article will explore non-U.S. medical device development regulations.

Class Determines Extent of Trials

Medical device classes are key to understanding device trials as certain classes require specific premarket submissions requirements.

Class I devices are, for the most part, exempt from premarket submission. These types of devices are considered low risk. Class I devices include:

  • Bandages
  • Stethoscopes
  • Bedpans

Class II devices carry higher risk than Class I devices. Class II devices require 510(k) premarket notification. Most medical devices fall in this category. Examples of Class II devices include:

  • Contact lenses
  • Absorbable sutures
  • Catheters
  • Hair removal devices

Lastly, Class III devices carry high risks for patients/administrators and require a premarket approval application. Class III devices:

  • Pacemakers
  • Breast implants
  • Cochlear implants

So, what is the difference between a 510(k) premarket notification and a premarket approval application, commonly referred to as a PMA?

A 510(k) premarket notification requires substantial equivalence, performance testing, and studies are dedicated by the ability of bench and animal testing to answer questions and the level of difference between device and predicate. Ten to 15% require clinical data.

PMA Applications More Intense

Premarket approval application clinical trials are more involved. Clinical studies must encompass both feasibility and pivotal studies. There are three stages of review for most premarket approval applications:

  1. Presubmission (in this stage the sponsor discusses design of the device, bench tests, animal testing, and clinical trial plans)
  2. Investigational Device Exemption (this occurs for medical devices that carry significant risk and the device is not approved for the indication being studied)
  3. Premarketing approval application

If the sponsor decides to upgrade the device, a fourth stage follows involving a premarket approval application supplement and a new Investigational Device Exemption. 

In simpler terms, trials that fall under premarket approval applications follow a cycle of bench testing, animal studies, and human studies. The greater the potential risk to patient safety for a proposed medical device then the greater is the burden of evidence to provide a high level of assurance.

The medical device market continues to grow. Combination products and “smart” devices that interface with software, including mobile apps, will be part of the next wave of medical innovation.

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