Blogs

The US Food and Drug Administration (FDA) has issued a draft guidance proposing lowering the risk classification for external pacemaker pulse generators from Class III to Class II. The change would remove such devices from the list of 22 remaining Class III medical devices on the market prior to the Medical Device Amendments Act of 1976 that continue to be reviewed under the 510(k) program rather than Premarket Approval.

• FDA: New draft guidance for external pacemaker pulse generators (Mass Device)
• FDA proposes lowering external pacemakers to Class II device (Cardiovascular Business)