FDA to Allow Combo Products to Submit Malfunction Summary Reports

The FDA is allowing manufacturers of combination products to submit certain device malfunction medical device reports on a quarterly basis.

The agency had earlier streamlined reporting requirements for Class I devices and Class II devices that are not permanently implanted or life supporting or sustaining. The summary reports do not apply to Class III and implantable or life-sustaining Class II devices.

There are still reportable malfunctions for which devicemakers will need to submit individual malfunction reports more often than quarterly to protect public health, the agency said.