Annex I, 23.4. Information in the instructions for use(z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is establishedIs actual practice and expectation to include a canned statement to this effect in every IFU?
Two-part question:1) We have an FDA-cleared neonatal phototherapy device (Class II, 510(k) in 2019). We are in the process of launching a line of swaddling garments (not medical devices on their own) that can be used to comfort neonates in the NICU and/or in other areas of the hospital. As long as we are clearly not marketing the two together and the garment is not intended to be used with our phototherapy device, the two products can co-exist, correct?2) In the future we wish to explicitly market the two products together. We will have evidence to support claims that the garment supports and augments the performance of the phototherapy device, we will have established a DHF and other design control measures for the garment, and we would update our IFU for the phototherapy device. We are lead down the path of a new 510(k) due to changes in contraindications (source: FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device). Does the fact that we will have previ
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