FDA Ultrasound Guidance Removes 510(k) Special Report Recommendation
This article was originally published in The Gray Sheet
Executive Summary
An ultrasound manufacturer no longer needs to submit a "510(k) special report" prior to shipping a new device as long as it keeps appropriate records in its design history file, according to an FDA 1guidance issued Sept. 9
You may also be interested in...
Current Fetal Ultrasound Practices Could Increase Risks, Studies Suggest
A sharp increase in the use of fetal ultrasounds in recent years in women with healthy pregnancies from an average of 2 scans to 5 scans per pregnancy and recent warnings from medical societies could prompt FDA to look more closely at possible risks to the fetus from ultrasound.
DIAGNOSTIC ULTRASOUND 510(k)S COULD INCLUDE THIRD-PARTY CERTIFICATION IN LIEU OF CERTAIN SAFETY DATA, FDA SAYS IN DRAFT REVISED GUIDANCE DOCUMENT
Manufacturers of diagnostic ultrasound systems could submit third-party certification of compliance to certain voluntary standards in 510(k)s instead of submitting actual performance data covered by the standards under draft revisions to FDA's guidance document for diagnostic ultrasound systems and transducers.
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.