The US Food and Drug Administration has published draft guidance establishing two pathways for medical...

Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.

Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?

During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an Letter to...

New Manufacturer Evaluation Codes for use in medical device reports have been established by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

The US Food and Drug Administration appears likely to require premarket assessments rather than premarket notifications for surgical mesh devices used to treat pelvic organ prolapse (POP) but not for stress urinary incontinence (SUI) in women.

New guidance from the US Food and Drug Administration recommends investigational device exemptions (IDEs) and Investigational New Drugs (INDs).

A final FDA rule affecting ventricular bypass devices , pacemaker repair or replacement material

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding