AG/FDA Blog

MDR Reporting of Foreign Adverse Events -- What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: The… Read More
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Warning: FDA Tightens Up Regulations for Tanning Beds

You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed to tanning beds. It has been all over the news – FDA’s Center for Device and Radiological Health (CDRH) was like a moth to a tannin… Read More
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Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

By Kathryn E. Balmford Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical… Read More
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What's Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. Th… Read More
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