What an FDA medical device submission contains
What goes into a 510(k), De Novo, PMA or HDE submission to FDA, with format rules and review timeframes.
Tag: fda
10 posts
FDA quality system requirements for medical devices
How 21 CFR Part 820 applies the QMSR to device manufacturers, which devices need design and development controls and how combination products are treated.
FDA post-market obligations for medical devices
How 21 CFR Parts 803, 806 and 822 govern adverse event reporting, corrections and removals and ordered postmarket surveillance for US devices.
FDA labeling rules for medical devices
How 21 CFR Parts 801 and 809 govern device claims and label content, from UDI and prescription statements to IVD package inserts.
What CLIA requires of a laboratory before it reports a result
How CLIA certification, performance specification validation and personnel qualifications apply to a laboratory before it reports a patient test result.
What evidence FDA requires for medical devices
What must be proven under each FDA device marketing route and the kinds of study that satisfy 21 CFR parts 807, 814 and 860.
Analytical validity, clinical validity and clinical utility
How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.
FDA rules for clinical studies of medical devices
How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.
Which FDA route a device qualifies for, 510(k), De Novo or PMA
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 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.