Compliance with FDA regulations and guidance related to medical devices can be a challenge. Medical device manufacturers must comply with the FDA’s DHF, including its derivative documents, the DMR and DHR. According to the FDA, it provides classifications for more than 1,700 different generic types of devices and groups them into 16 medical specialties referred to as panels. The FDA has also issued two guidance documents on medical device cybersecurity. Manufacturers must also ensure they understand the FDA’s draft guidance on 3D medical printing devices.
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