- The FDA has issued draft guidance for medical device makers on how to request nonbinding feedback on certain kinds of Form 483 deficiencies noted during on-site inspections. The objective is to enable them address the issues in a more timely and consistent fashion. Previously, companies could only request feedback on their planned corrective actions.
- A request for nonbinding feedback will be required to show how one or more observations meet statutory criteria, involve a public health priority, implicate systemic or major actions or relate to emerging safety issues. The agency will respond with 45 calendar days after receiving the request.
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