FDA Expresses Commitment To Development Of Devices For Patients With Disabilities

By Nick Otto

The FDA recently emphasized its push to empower the medical device industry in studying and developing new technologies to treat patients with disabilities.

In a blog post last week, William Maisel, the FDA’s deputy center director for science and chief scientist for the Center for Devices and Radiological Health (CDRH), says the agency is committed to encouraging innovation to benefit patients.

Examples of devices that have recently made their way through the FDA’s premarket requirements, according to the blog post, include:

• The DEKA Arm System, a prosthetic arm that can perform multiple, simultaneous, powered movements controlled by electrical signals from electromyogram electrodes;
• The Nucleus Hybrid L24 Cochlear Implant System, which can help people 18 years of age and older – who don’t benefit from conventional hearing aids – with a specific kind of hearing loss; and
• The Argus II Retinal Prosthesis System, a device to treat adult patients with vision loss from advanced retinitis pigmentosa.

Maisel acknowledges the agency’s encouragement of the FDA’s personal interaction with developers to clarify the “expectations for product evaluation.”

As an example, he points to the summer approval for a robotic exoskeleton device that offers “powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk.”

“We have seen amazing advances in technology in recent years,” Maisel says. “These advances make it possible for manufacturers to address longstanding disabilities in innovative ways.” In doing so, the FDA will make all efforts to ensure fair and balanced decisions in approving devices and that approved products will “aid the patients who use them.”

In addition to inspiring and working with industry to promote innovation, the blog post adds that the agency provides internal support to FDA employees with disabilities.

Recently, according to Maisel, FDA Commissioner Margaret Hamburg hosted a meeting with the agency’s Advisory Committee for Employees with Disabilities, providing updates on internal projects such as making all building accessible to disabled persons, and increasing access to assistive and adaptive technologies through a new ergonomic resource center at the FDA’s headquarters.

“People with disabilities make many important contributions to our agency and to society at large,” he says. “It’s our goal and commitment to help them maintain an active lifestyle and enjoy a good quality of life.”