Section
Molding, extrusion, machining, electronics, catheter and tubing, cleanroom assembly, automation, additive, software and firmware, test.
Of the process-change supplements FDA received in 2015-2023, 927 records were converted from the 30-day notice route to the 135 Review Track, 6.3% of the notices filed. For notices received in 2018-2023, those supplements were approved a median 204 calendar days after receipt.
Molding, extrusion, machining, electronics, catheter and tubing, cleanroom assembly, automation, additive, software and firmware, test.
Every factual claim links to a primary source, standards are cited by number and year, and sponsored and contributed pieces carry a label. That is the whole method, and it is written out on the ethics policy.
This section has its own feed at /manufacturing/feed. The FDA data on this site does not wait for the newsroom: clearances, recalls, product codes and company records are live at the data hub.
