Where the line runs between a laboratory-developed test and an IVD
How 42 CFR Part 493 and the in vitro diagnostic definition in 21 CFR Part 809 treat a test that a laboratory develops, modifies and runs itself.
Tag: classification
4 posts
Working through the IVDR classification rules
How Annex VIII of Regulation (EU) 2017/746 assigns in vitro diagnostics to classes A, B, C and D, and what each class determines.
How the EU classifies medical devices
How Annex VIII of Regulation (EU) 2017/745 assigns medical devices to class I, IIa, IIb or III, and the rules that decide which class applies.
How FDA classifies medical devices
How FDA assigns devices to class I, II or III under 21 CFR Part 860, covering classification regulations, De Novo requests and 510(k) exemptions.