Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.
PMID: 42324971 ·
Helen Banks, Maria Luisa Buzelli, Ornella Tangila Kayembe, Nicolas Martelli, Majella Geraghty, Giuditta Callea
JournalExpert review of medical devices
Year
PMID42324971
Abstract
Early Feasibility Studies (EFS) enable limited early-stage clinical evaluation of novel medical devices when non-clinical testing is insufficient to inform design, safety, or performance. While the US Food and Drug Administration has an established EFS program, the EU lacks a dedicated framework, creating uncertainty for innovators and regulators. This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed,
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