FDA to Accept IEC Standards in 510(k) Submissions for Diathermy Devices

The FDA issued draft guidance on compliance policies for 510(k) submissions for ultrasonic diathermy devices.

When the guidance is finalized, manufacturers conforming with the International Electrotechnical Commission (IEC) standards — IEC 60601-2-5 and IEC 61689 — will not have to comply with the radiation safety performance standards in 21 CRF parts 1010 and 1050.10, the agency said.

The change will help manufacturers avoid duplicate efforts. The agency acknowledged the advantages of a universal set of device-specific criteria and requirements and said conformance with certain IEC standards would provide at least the same level of protection of the public health and safety from electronic product radiation as the FDA performance standards for ultrasonic therapy products.

Class II ultrasonic diathermy devices are used to apply deep heat within a patient’s body to treat conditions like muscle spasms and joint contractures. Not all medical devices that use ultrasound are included in the scope of the guidance. It applies only to devices employing ultrasonic 73 energy at a frequency beyond 20 kilohertz using a single plane circular transducer per treatment 74 head producing non-convergent beams perpendicular to the face of the treatment head.

Under the new guidance, the FDA will not have confirm a manufacturer’s compliance with 21 CRF 1050.2 if it conforms to the identified IEC standards and include the following statement in device labeling:

“Complies with 21 CFR Subchapter J, except for conformance with IEC 60601-2-5 and 120 IEC 61689 instead of the performance standards in 21 CFR 1050.10. See for more 121 information FDA’s guidance ‘Policy Clarification and Premarket Notification [510(k)] 122 Submissions for Ultrasonic Diathermy Devices,’ dated August 31, 2017.”

Manufacturers choosing to comply with the IEC standards should include the information listed in the guidance in their 510(k) submissions.

Read the draft guidance here: www.fdanews.com/08-31-17-DiathermyGuidance.pdf.