www.fdanews.com/articles/188170-fda-to-allow-combo-products-to-submit-malfunction-summary-reports
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FDA to Allow Combo Products to Submit Malfunction Summary Reports
August 27, 2018
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.