The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions.
Ultrasonic therapy devices are considered both medical devices and electronic products and need to comply with radiation safety performance standards in 21 CFR 1010 and 1050.10 as well as certain International Eletrotechnical Commission (IEC) standards.
The devices produce high-frequency sound waves — transmitted through a wand applied to the skin — that travel deep into tissue to create therapeutic heat to treat pain, muscle spasms and joint contractures.
The FDA said that complying with both FDA and IEC standards can cause manufacturers to duplicate their efforts, and it said that conformance with the IEC standards would provide the same level of protection as the FDA’s performance standards.
Although conformance with IEC standards would satisfy FDA performance standards, manufacturers must still comply with other FDA requirements including submitting 510(k) applications using IEC data. The guidance applies only to ultrasonic diathermy products regulated under 21 CFR 890.5300(a), product codes IMU and PFW, which are Class II devices.
Manufacturers must provide IEC certifications for their products in their 510(k) submissions. They must furnish certifications to dealers or distributors that the product conforms to applicable standards, and the certification must also be provided on a label or tag permanently affixed to the product.
The FDA said the tag should read: “Complies with 21 CFR Subchapter J, except for conformance with IEC 60601-2-5 and IEC 61689 instead of the performance standards in 21 CFR 1050.10. See for more information FDA’s guidance ‘Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices,’ dated April 16, 2018.”
The guidance provides further information to be included in a 510(k) submission, including device descriptions, predicate device comparison information, software performance test data, biocompatibility information for patient-contacting materials, electrical safety and electromagnetic compatibility, wireless technology standards, labeling, and cleaning and reprocessing.
The agency said it received no comments on the draft guidance, which was released on Aug. 31, 2017.
Read the final guidance here: www.fdanews.com/04-18-18-Diathermyguidance.pdf.