FDA Sets (Another) Deadline For Releasing Draft Harmonized Quality System Regulation
October 2020 is the new in-house target date for the US agency to release a draft of its revised QSR, which will be harmonized with international quality systems standard ISO 13485.
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Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485
Melissa Torres, a US FDA official who is one of many working on the agency’s revision of the Quality System Regulation, offered a few nuggets of news about the process on 8 June. Among them: device makers will have “a few years” to comply with the new QSR; the Quality System Inspection Technique (QSIT) will change; investigators and device center staff will undergo training; and more.