FDA Policy/General

6 Medical Device Classification Notices

Federal Register notice: FDA has published the following six medical device classification notices:

Clinical chemistry and clinical toxicology devices — De novo classification of Astute Medical’s Nephrocheck Acute Kidney Injury Test System.
Immunology and microbiology devices — De novo classification of Quidel Corp.’s Lyra Direct Streptococcus SPP Nucleic Acid-Based Assay.
Immunology and microbiology devices — De novo classification of Kronus, Inc.’ Aquaporin-4 Autoantibody ELISA Immunological Test System
Immunology and microbiology devices — De novo classification of Wallac Oy’s EnLite Neonatal TREC Newborn Screening Test for Severe Combined Immunodeficiency Disorder.
Gastroenterology and urology devices — Correction of de novo classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss. FDA has clarified that premarket notification is required for such devices.
Neurological devices; Correction of de novo classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System. FDA has clarified that premarket notification is required for such devices.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome