Dear members, Neil Plumridge spotted the following Politico article regarding updates to FDA classifications:
Devices, diagnostics and digital health
- CLASSIFICATION ORDER BONANZA: The FDA’s Center for Devices and Radiological Health today issued nine medical device classification orders, primarily (eight out of the nine) for diagnostic products. The issuance of these orders is the last step in formally codifying a new device type as a Class II (moderate risk) product after a De Novo request is granted to establish the new product type. However, the act of granting the De Novo request itself actually creates the new regulatory record – the classification orders are more of an administrative step – meaning that all of these device types were already established and available in regulation. The records span over a decade of De Novo authorizations granted for nine new device types since 2013. In order of year in which the De Novos were granted: Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox (2013); Postnatal Chromosomal Copy Number Variation Detection Systems (2014); Anti-Phospholipase A2 Receptor Immunological Test Systems (2014); Devices that Detect Nucleic Acid Sequences from Microorganisms Associated with Vaginitis and Bacterial Vaginosis (2016); Multiplex Respiratory Panels to Detect and Identify Emergency Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens (2017); Cancer Predisposition Risk Assessment Systems (2018); Menopause Test Systems (2018); Pharmacogenetic Tests Systems (2018); Laparoscopic Gastrointestinal Sizing Tools (2020). It’s not clear why CDRH is cleaning up and dotting its i’s now, but it could have something to do with the “regulatory cap” or budget that the White House is putting on agencies for fiscal year 2026, as granting devices in a lower-risk category under a De Novo is considered a “deregulatory” action by the FDA.
