Category

FDA Updates Regulatory Affairs Newsletter Archive

FDA New Classifications published FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA New Classifications published

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…
Ben Kemp
August 22, 2025
IEC 61326-2-6 Ed 4.0 2025-06 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IEC 61326-2-6 Ed 4.0 2025-06 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Dear members, The FDA yesterday announced its complete recognition of the International Electrotechnical Commission’s standard IEC 61326-2-6 Edition 4.0 2025-06. The standard applies to basic safety and essential performance of in vitro diagnostic medical electrical equipment when exposed to electromagnetic disturbances.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number…
Ben Kemp
August 4, 2025
FDA reclassifications FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA reclassifications

FDA have announced a number of reclassifications of Class III devices to lower classifications such as Class II ( with special controls). These include: muscular dystrophy newborn screening tests herpes simplex virus nucleic acid-based assay for central nervous system infections fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies lysosomal storage disorder newborn screening test systems.
Ben Kemp
July 4, 2025
FDA reclassifications FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA reclassifications

Please note that this consultation closes 11th August 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing…
Ben Kemp
July 4, 2025
FDA Consensus Standards FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025
FDA Guidance – June 2025 FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance – June 2025

These are the updates published since 07/01/2025 (when we last put updates on regulatory newsletter) up to and Including 29/05/2025. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program | FDA Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff | FDA Data Standards Catalog | FDA…
Ben Kemp
June 9, 2025