The FDA updated its reporting on its newly streamlined de novo medical device review pathway, detailing products the agency has cleared so far.
The update includes approval letters and decision summaries that the agency hopes may serve as a resource for other device makers hoping to submit devices for de novo review.
De novo review aims to streamline regulatory review for medical devices that are considered low-risk but were previously put through the more stringent premarket approval process because there were no existing devices that might be considered predicates for streamlined 510(k) review.
Medical device makers can request that the FDA assess a new device application and make a risk classification that may bump the device to a more relaxed review category. Applicants can submit directly for de novo review or appeal a "not substantially equivalent" assessment given for a failed attempt at a 510(k).
The federal watchdog agency provided links for all available de novo summaries and approval letters to date:
|Infrascanner Model 1000||Approval Letter||Decision Summary|
|Zeltiq™ Dermal Cooling Device||Approval Letter||Decision Summary|
|Erchonia ML Scanner||Approval Letter||Decision Summary|
|NuMED NuCLEUS and NuCLEUS-X BAV Catheters||Approval Letter||Decision Summary|
|Hem-Avert Perianal Stabilizer||Approval Letter||Decision Summary|
|RIDASCREEN Norovirus 3rd Generation EIA||Approval Letter|
|Prostate Mechanical Imager||Approval Letter||Decision Summary|
|LipiFlow Thermal Pulsation System||Approval Letter||Decision Summary|
|Steris Verify Spore Test Strip for S40||Approval Letter||Decision Summary|
|InBios DENV Detect IgM Capture ELISA||Approval Letter||Decision Summary|
|Widex C4-PA Wireless Air-Conduction Hearing Aid||Approval Letter||Decision Summary|
|Aptus Endovascular Suturing System||Approval Letter||Decision Summary|
|ImmunoCAP Tryptase||Approval Letter||Decision Summary|
|Percutaneous Surgical Set with 5 mm or 10 mm Attachments||Approval Letter||Decision Summary|
|STRATIFY JCV Antibody ELISA||Approval Letter||Decision Summary|
|PORTRAIT TOXIGENIC C. DIFFICILE ASSAY||Approval Letter||Decision Summary|