'Good Lab Practices' Don't Apply To Early Device Work: FDA

Law360, New York (August 27, 2013, 5:51 PM EDT) -- The U.S. Food and Drug Administration on Tuesday told medical device manufacturers when they must adhere to so-called good laboratory practices in early stage research, clarifying that such standards don’t apply to initial efforts at gauging potential effectiveness.

In draft guidance, the FDA said it was addressing common questions about the scope of regulations issued 35 years ago regarding quality guidelines that cover nonclinical research, such as test tube experiments or animal studies.

A key takeaway appeared to be the FDA’s position that the earliest research...
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