FDA redefines 510(k) special controls

Noting the confusion over the updated 510(k) clearance process, the FDA has released a clarification of the rules governing Class II medical devices, especially the "special controls" designated by the governing body. The agency also has scheduled a public workshop to discuss clinical trial requirements.

"In order to comply with the special controls guidance, manufacturers must address each identified risk to health presented in the guidance for the Class II device by either meeting the recommendations of the guidance or by some other means that provides equivalent assurances of safety and effectiveness," the FDA said, according to MassDevice. According to the FDA, those special controls can include labeling requirements, performance standards and continual follow-up on the devices.

- read the MassDevice piece

Suggested Articles

The agency also gave the company’s diagnostic, run on the high-throughput Panther Fusion laboratory platform, a green light for pooled testing.

Smith & Nephew has signed up to acquire Integra LifeSciences’ orthopedics business focused on the growing upper and lower extremity markets.

The company describes the continuous glucose monitor as the world’s smallest and thinnest diabetes sensor, with a disc about the size of two pennies.