USA – FDA drafts guidance to aid orthopedic implant guide makers
The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
USA – Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed...
The US Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have formed a partnership aimed at curbing medical device shortages. A 22...
USA – FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance
The US Food and Drug Administration has updated its final guidance on its Q-Submission program in line with changes negotiated in the recent medical...
Canada – Proposed changes to the Medical Devices Regulations to address future public health...
Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We're proposing to expand the current provisions under Part 1.1 of the MDR, currently...
USA – AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance
The medtech lobby group AdvaMed has asked the US Food and Drug Administration (FDA) to make changes to its recent guidance on orthopedic non-spinal...
USA – FDA finalizes guidance for containment system used with power morcellators
The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems...
USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
