Experts: Strong design controls are key to FDA device approval

LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure that devices work as intended without compromising safety and effectiveness, according to two experts speaking at the RAPS Global Regulatory Strategy Conference on Tuesday.

At the meeting, Brandon Woll and Wendy Schroeder, who are consultants with NAMSA, discussed how to get devices through the pipeline from development to approval. Woll addressed significant risk devices that require an investigational device exemption (IDE), while Schroeder focused on in vitro diagnostic devices that are considered non-significant risk devices that are not subject to an IDE.

Woll said that companies can bridge the gap between product development and IDE readiness “through proper design controls and proper understanding of the use environment for the device.”

Prior to joining NAMSA, Woll worked in the quality and product development space for Medtronic where he worked on cardiovascular catheters, skin grafts, stents, balloons, and valves.

Challenges

One of the first questions Woll asks clients who want to get their IDEs approved is whether they have a design history file.

“My first step is always ‘can we take a step back? I would like to see your design history file. I would like to see how you are defining your design inputs and your use conditions. Will it be used in the operating room or will it be used alongside other components and other devices?”

Other questions are whether the device is being used with electronic monitors or other electronic devices and whether sponsors understand how these devices will interact or whether there will be interference between the devices.

All of this information will drive the testing that needs to be done.

“I assure you that FDA will be asking the same questions, how much do you understand the way it is used and show me how this understanding in the way you have tested the devices,” Woll added.

FDA will also be asking questions on whether the simulated use model is the worst case, and whether different places of the anatomy are worst case uses. The agency wants to know how these questions will drive sponsors’ testing programs.

Schroeder concurred on the need for robust design controls for in vitro diagnostics (IVDs). She said that even for non-significant risk devices that do not need an IDE, sponsors “still have to comply with design controls.”

She offered an example where a client lacked multiple design controls for an IVD. The product had no scalable quality control and had no user instructions. In such cases, Schroeder said, “We have to … dial back a little bit.”

Sponsors need to go back and assess whether there are interfering substances with the assay and understand whether different sample preparations will translate into different results. “If I prep my samples differently from day 1 to day 30, will the results still be accurate?”

Schroeder added that even though many IVDs are not subject to IDEs, sponsors still need to get informed consent when interacting with human subjects. She worked with a client who did not want to obtain informed consent for a blood drawing device intended for use on patients under anesthesia. The client wanted a waiver from obtaining consent.

“I’m sorry, if my loved one is in that bed and you came and got their blood and did not tell me, I would be really mad. That is the ethical part.” She added that “you are still obligated to get consent to get someone’s blood.”

She said that this would be a different story and a different use condition if the device draws leftover blood, or stores blood from leftover samples.

What to submit

Woll said that IDE submissions should include an application cover letter, the sponsor's name and address, the investigator agreement, a report of prior investigations, a list of investigators, the name and address of the participating institutions, the amount charged for the device, and the GMP controls used in manufacturing, processing, packaging, storing and installing the device.

Woll said that reports of prior investigations can constitute 70 to 80% of the IDE submission.

He noted that FDA can reject an IDE for several reasons. One reason could be that the agency finds the laboratory testing methods to be inadequate. Other potential reasons for disapproval include insufficient validation of sterilization processes, inadequate biocompatibility evaluations, and incomplete manufacturing controls.

Additional reasons include a lack of justification for using animals in studies, insufficient rationale for the number of animals chosen, and an unsuitable duration of these studies.

Woll emphasized the importance of involving regulatory staff in the IDE submission process. He explained that these personnel are often generalists with a broad understanding of all aspects of medical device design and development. Additionally, they can assist regulators in comprehending how the safety and effectiveness of these devices are demonstrated from both clinical and nonclinical perspectives.

Experts: Strong design controls are key to FDA device approval

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