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2. A US manufacturer is developing their manufacturing facility to accommodate both Class I and Class II devices production. They intend to market all products
2. A US manufacturer is developing their manufacturing facility to accommodate both Class I and Class II devices production. They intend to market all products in the US, including some specific Asia-Pacific markets. If their US manufacturing facility will undergo the US FDA inspections to assure compliance with the QMS requirements, which CFR will apply
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