Bearing the Burden of "Innovation": The Ontological Implications of Substantial Equivalence and the FDA 510(K) Pathway.

Maldonado F, Eberl J. Bearing the Burden of "Innovation": The Ontological Implications of Substantial Equivalence and the FDA 510(K) Pathway. Chest. 2023 May;163(163). 1225-1227. PMID: 37164576 [PubMed]