FDA Law Blog

SEPTEMBER 17, 2023

CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation. If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Getting to Building 66 Most CDRH meetings occur in Building 66.

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FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.

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PEMBlog

MARCH 27, 2024

Now, newborn screening, or NBS, includes testing newly born infants for certain IEMs. You won’t be able to diagnose them on history and physical alone. Therefore, in the ED, the goal is really to recognize the science and symptoms on history and physical exam that are suggestive of metabolic disease. I will take an email.

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