Tag: fda

How FDA evidence standards work for NDAs, 505(b)(2) applications, ANDAs and biologics licenses, including accelerated approval and the animal rule.

How 21 CFR part 820 became the Quality Management System Regulation, which sections were removed or reserved, and where each requirement now sits.

When an IND is required under 21 CFR Part 312, the exemptions, and the informed consent and investigator duties that govern FDA-regulated drug trials.

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.

What goes into a 510(k), De Novo, PMA or HDE submission to FDA, with format rules and review timeframes.

How 21 CFR Part 820 applies the QMSR to device manufacturers, which devices need design and development controls and how combination products are treated.

How 21 CFR Parts 803, 806 and 822 govern adverse event reporting, corrections and removals and ordered postmarket surveillance for US devices.

How 21 CFR Parts 801 and 809 govern device claims and label content, from UDI and prescription statements to IVD package inserts.

How CLIA certification, performance specification validation and personnel qualifications apply to a laboratory before it reports a patient test result.

What must be proven under each FDA device marketing route and the kinds of study that satisfy 21 CFR parts 807, 814 and 860.

How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.

How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.

How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.

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.