FDA has issued Guidance on the use of Predetermined Change control plans for AI enabled device software functions.
Ben KempSeptember 8, 2025
Please see the two updated FDA Guidance documents from June 2025: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA Unique Device Identifier Requirements for Combination Products | FDA
Ben KempAugust 28, 2025
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 KempAugust 22, 2025
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 KempAugust 4, 2025
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 KempJuly 4, 2025
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 KempJuly 4, 2025
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 KempJune 9, 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 KempJune 9, 2025