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s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very well, either.

“The adequacy of your firm’s response dated Nov. 20, 2013, cannot be determined at this time,” FDA’s warning letter said. “Your firm’s response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.”

Electronic Development Labs makes the NervoScope.

The agency also gently encouraged the company to look into electronic medical device reporting (eMDR).

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