FDA details medical devices approved through de novo fast-track

August 20, 2012 by MassDevice staff

The FDA updates its list of medical devices approved through the de novo review pathway, reserved for medical devices that are novel but represent low risks to patients.

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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.

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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:



Device Name    
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

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