Medical Device Cybersecurity: manufacturers must design, develop, and maintain processes and procedures to provide a reasonable assurance that the dev...
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Temporary enforcement discretion for pending Unique Facility Identifiers (UFI) is no longer available. The option to select the "Pending UFI Option" f...
If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance a...
Menstrual products (tampons, pads, menstrual cups) are regulated by the FDA as medical devices while intimate care products (douches, wipes, washes, s...
Our clients around the world are mostly startups, small and medium-sized enterprises (SMEs). Gen-Xers account for the largest portion of small busines...
Fact: Dietary supplements are not FDA-approved to treat or prevent diseases. You should know that the FDA does not approve dietary supplements for saf...
Madagascar Cocoa Beans: No other cacao is so widely used by small craft chocolate makers around the world. There is good reason for this. ITB HOLDINGS...
