I designed the search strategy for an FDA device submission: approximately 10,000 records screened, 629 full-text articles assessed, and 163 studies appraised and extracted into evidence tables. The work used eight quality criteria and a screening log with 16 exclusion categories. This case study shows the method and table structure only, with no client, device or confidential data.
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FDA device literature review: search strategy design, ~10,000 records screened, 163 studies appraised, eight quality criteria, audit-ready evidence tables.
