US FDA Ponders Using MDSAP Audit Results In Lieu Of Pre-Approval Facility Inspections
The agency is considering ways to leverage outputs from the increasingly popular Medical Device Single Audit Program in new and diverse ways, including accepting MDSAP audit results instead of conducting its own pre-market approval inspections.
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The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.
The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.
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