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Regulatory Briefs: Pre-Amendment Reclassifications; Upcoming FDA Meetings

FDA finalizes rules reclassifying intra-aortic balloon devices, external counter-pulsating devices and temporary mandibular reconstruction plates. Orthopaedic and ophthalmic device advisory panel meetings announced.

FDA issued a final rule Dec. 30 reclassifying intra-aortic balloon and control system devices, a pre-amendment device type, from class III to class II with special controls and subject to the 510(k) pathway when they are indicated for acute coronary syndrome, cardiac and noncardiac surgery or complications of heart failure. FDA is requiring PMAs for the devices when they are indicated for septic shock or pulsatile flow generation. PMAs for products with these indications must be filed within 90 days of the final rule’s Dec. 30, 2013, effective date. Previously, the devices went through the 510(k) pathway for all indications.

The final regulatory scheme for the device type is unchanged from that recommended in FDA’s June 2013 proposed order, which received only one public comment. The technology consists of an...

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