MDSAP Audit Approach (MDSAP AU P0002)
Chapter 4: Medical device adverse events and advisory notices reporting – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C4-T2-US: United States: report corrections and removals made to reduce a risk to health or remedy a violation within 10 working days, with device identifiers, and keep records of unreported ones

What does C4-T2-US require?

Manufacturers must have a process to notify the FDA of device corrections and removals and keep records of them (21 CFR 806, 820.10(b)(4)). A written report of any correction or removal begun to reduce a health risk, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act that may present one, is due within 10 working days of starting it and must include the UDI (or device identifier, UPC, model, catalogue or code number) and the lot or serial number. Corrections and removals that need no report (for example minor violations with no health risk) must still be recorded with the same identifiers.

Maintained by Gerard Blokdyk

Other controls in Chapter 4: Medical device adverse events and advisory notices reporting – MDSAP Audit Approach (MDSAP AU P0002)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls