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.
Tag: medical-devices
9 posts
What evidence the EU requires for medical devices
How Regulation (EU) 2017/745 sets the clinical evidence for a CE marked device, covering clinical evaluation, investigations, equivalence and PMCF.
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.
When a medical device trial in China needs approval and when a filing
Which medical device trials in China need approval from the national regulator, which need only a filing, and what each route requires.
EU rules for clinical studies of medical devices
How Regulation (EU) 2017/745 governs clinical investigations of medical devices, which studies it covers and when authorisation or notification is needed.
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.
How the EU classifies medical devices
How Annex VIII of Regulation (EU) 2017/745 assigns medical devices to class I, IIa, IIb or III, and the rules that decide which class applies.
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.