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Submitting a 510(k)? Keep Hoarding Blank CDs

FDA Law Blog

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

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Episode 213: Antiracism in Medicine Series – Episode 13 – Centering Asian Americans: Racism, Violence, and Health

The Clinical Problem Solvers

provision in only English +/- Spanish), limitations of medical technology (i.e., In addition to the physical wrongs done to the victims, these acts function as community stressors that harm the mental, emotional, and physical wellbeing of so many others. Insufficient language services (i.e., link] The Practice (2019).