Understanding the FDA’s Clinical Investigation Process

When a healthcare facility considers adopting a new medical device or adding a new medication to its formulary, one of the first questions asked is, “Has it been approved by the FDA?”

Angie Mitchell, RN

Approval by the U.S. Food and Drug Administration (FDA) is vital for making decisions about which items to purchase, but as Angie Mitchell, RN, former assistant vice president of physician services at HealthTrust shares, many supply chain professionals and healthcare providers don’t fully understand how the FDA’s approval process works. A clearer understanding of the FDA’s inner workings may help healthcare organizations have appropriate expectations for new product releases and better appreciate what that required approval means.

Denise Dunco, MSN, RN

In November, Mitchell and Denise Dunco, MSN, RN, former manager of physician services at HealthTrust, attended the FDA’s three-day Clinical Investigator Training Course, receiving an insider’s look at the FDA approval process. Below, they share some insight that can offer HealthTrust members a deeper understanding.

A Closer Look at Clinical Trials

The responsibilities of a principal investigator conducting a clinical trial was a focus of the course. Attendees learned the basic design concepts of a clinical trial and what to look for in drugs and medical devices that are being investigated in a clinical trial. Mitchell shares that this information will assist HealthTrust members in reviewing clinical data for sources of bias and error. Those skills can provide them with more reliable information regarding drugs and medical devices that are undergoing clinical trials, enabling them to make more informed decisions for their facilities and patients.

In recent years, the FDA has promoted greater transparency into its decision-making process and instituted post-market surveillance. “The FDA was extremely open about what they share with study investigators, and I think they really want those conducting the review process to succeed,” Mitchell says. “Some people have the perception that you send clinical trial paperwork into the black hole of the FDA and wait for an answer, but from the information presented, it offers opportunities for pre- and post-meetings with the investigator and team to clarify questions and provide direction. Patient safety is the FDA’s No. 1 priority.”

More Clarity on Medical Device Approvals

The development of drugs and medical devices follows well-established pathways to make sure they are safe and effective when they reach the public. “Although the medical device pathway is different from drugs, the FDA’s standards are the same,” Dunco says. “The medical device pathway to approval is divided into three classes depending on the type of information needed to ensure safety and efficacy.” (See below for details on the three classes.)

The FDA is currently re-evaluating the way devices are approved under the 510(k) process. “Currently, a device is considered substantially equivalent if it has the same intended use and the same technological characteristics as a device that is already legally marketed,” Dunco explains. “To help keep pace with the increasing complexity of rapidly evolving technology, the FDA is modernizing the 510(k) clearance pathway, which accounts for the majority of devices the FDA reviews.”

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices. CDRH also oversees the manufacturing, performance and safety of these devices.

CDRH is working to achieve its vision of providing access to high-quality, safe and effective medical devices through several strategic priorities, Mitchell says. It plans to establish a national evaluation system for medical devices so that users can access and use real-world data for making decisions. The organization also partners with healthcare providers and patients to solicit their thoughts and opinions on regulatory decisions. Often before the FDA finalizes their approval for a category or product, they may open it up for public comment for a designated period.

As medical device approvals evolve, a deeper understanding of the process will help Mitchell, Dunco and their colleagues make more informed decisions about product approvals at HealthTrust. Before adding a new medical device to HealthTrust’s contract portfolio, clinical professionals who are often subject matter experts in that area review all the clinical device information. “We determine the type of FDA approval a device received, and we have a dedicated team member who continually monitors the FDA website for recalls or changes,” Mitchell says.

The Global Angle

The number of international sites and trial participants contributing data to support U.S. marketing applications for drug and device approval is increasing.

To expedite the approval process of both drugs and devices, the FDA does accept data from studies conducted internationally if the data meets criteria specified under FDA regulations. For instance, the study must be well-designed, performed by qualified investigators and conducted in accordance with good clinical practices. If necessary, the FDA must also be able to validate the data through on-site inspection.

Research and technology will continue to expand around the world as scientific minds uncover new treatments and medical devices to improve patient outcomes. And, the FDA will remain committed to ensuring that those new developments are safe and effective. Meanwhile, HealthTrust clinical experts will monitor such developments and keep its members informed about the latest in FDA approvals and recalls.

Differences Between FDA Medical Device Classes

Class I devices include items like cotton swabs, antimicrobial medical gloves, elastic bandages and tongue depressors. These devices are generally exempt from premarket submissions to the FDA.

Class II includes devices such as X-ray machines, powered wheelchairs, surgical drapes and some diagnostic tests. Most of these devices require a 90-day review before being cleared by the FDA. That review requires that the new devices be substantially equivalent to predicated devices, or existing similar products that have already been cleared. If a predicate device does not exist, the new device requires a 150-day review. If special controls can be designated that provide a reasonable assurance of the device’s safety and effectiveness it will be regulated by the FDA, explains Angie Mitchell, RN, former assistant vice president of physician services at HealthTrust.

Class III includes advanced devices such as defibrillators and implantable middle ear devices, digital mammography, minimally invasive and non-invasive glucose testing devices. These products require premarket approvals. These devices must have a 180-day review and additional regulatory oversight. Any risks for Class III devices cannot be mitigated by special controls.

Trials for new medical devices are different from drug trials in many ways. For instance:

• Device trials tend to enroll fewer participants.

• Many device trials assess iterative improvements to existing devices.

• Device design and procedures may be modified during the trial.

• Adaptive device designs are increasingly common.

• Existing data can substitute for prospective trial data.


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