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https://www.medtechdive.com/news/FDA-finalizes-combination-product-guidance/693498/
FDA finalizes combination product guidance 7 years after sharing draft | MedTech Dive
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
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https://www.medtechdive.com/news/fda-breakthrough-device-final-guidance-health-equity/693781/
FDA finalizes breakthrough device changes to target health inequities | MedTech Dive
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
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https://www.medtechdive.com/news/fda-finalizes-guidance-on-diagnostic-ultrasound-systems/557749/
FDA finalizes guidance on diagnostic ultrasound systems | MedTech Dive
The text hews closely to the draft the agency issued in 2017, the core of which detailed its policy on 510(k) filings.
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