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