CDRH New Update

The following new items were added to the CDRH web pages on October 27, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request - Guidance for Industry and Food and Drug Administration Staff
• Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Guidance for Industry and Food and Drug Administration Staff
• De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff
• Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff
• Webinar - De Novo Classification Process (Evaluation of Automatic Class III Designation) - November 21, 2017
• FDA Voice Blog: The Mammography Quality Standards Act – a 25-year Public Health Success Story
• Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of Acute Kidney Injury Test System
• Federal Register: Gastroenterology-Urology Devices; Classification of Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
• Federal Register: Immunology and Microbiology Devices; Classification of Aquaporin-4 Autoantibody Immunological Test System
• Federal Register: Immunology and Microbiology Devices; Classification of Newborn Screening Test for Severe Combined Immunodeficiency Disorder
• Federal Register: Immunology and Microbiology Devices; Classification of Streptococcus SPP. Nucleic Acid-Based Assay
• Federal Register: Neurological Devices; Classification of Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
• Federal Register: Acceptance Review for De Novo Classification Requests
• Federal Register: De Novo Classification Process (Evaluation of Automatic Class III Designation)
• Federal Register: Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request
• Federal Register: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices
• Federal Register: Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop