Introduction to US FDA Medical Device Regulatory Process
Introduction to US FDA Medical Device Regulatory Process
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FDA ADMINISTRATIVE ORDER NO. 2018-0002 || Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN HARMONIZED TECHNICAL REQUIREMENTS. - Food and Drug Administration
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Today, the FDA identified a Class I Recall, the most serious type of recall: Medtronic expanded its 2018 recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic updated recommendations for people who may still be using the remote controllers, including instructions to stop using and return the remote controller. Find out more about this medical device recall: https://go.usa.gov/xMwr
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