Compliance Corner: 20 Things You Should Never Say To An FDA Investigator
Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.
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The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
ANSI/AAMI ST79:2017 has gained four new amendments, including recommendations and clarifications for “maintaining the integrity” of sterile process areas. The standard is used by health care professionals who use steam to sterilize devices and other medical products.
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.