FDA recognition of standards
This article was originally published in The Gray Sheet
Executive Summary
Draft guidance on use of the International Electrotechnical Commission's 60601 safety standards for devices will not be finalized, FDA says in an Oct. 16 Federal Register notice. Instead, the agency formally recognizes the 60601 standards by listing them in the notice, along with 240 other standards posted on FDA's website in August. "There appears to be little, if any benefit to finalizing guidance on FDA's use of IEC 60601 standards in a separate document," the notice says