As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 8月 18日

August 23rd Deadline for FDA Final Rule on Three Obsolete Class III Devices

A final FDA rule affecting ventricular bypass devices , pacemaker repair or replacement material
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2011年 8月 29日

FDA Recommends Risk-Based Approaches to Monitoring Clinical Investigations

New guidance from the US Food and Drug Administration recommends investigational device exemptions (IDEs) and Investigational New Drugs (INDs).
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2011年 8月 30日

New Saudi Regulations in Effect for Medical Device Importers

Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
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2011年 9月 1日

FDA: PMA Requirements for Surgical Mesh Devices Possible

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.
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2011年 9月 2日

New Manufacturer Evaluation Codes in Place at FDA

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).
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2011年 9月 8日

AdvaMed Study: Medical Device Excise Tax Would Be Terrible

A new study funded by US medical device industry lobbying group AdvaMed anticipates job losses,...
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2011年 9月 9日

CDRH Issues Additional Import Entry Review Process Recommendations

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an Letter to...
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2011年 9月 14日

FDA Mobile Apps Workshop: Panelists Grapple with Apps-as-Accessories Issue

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.
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2011年 9月 14日

FDA Mobile Apps Workshop: Can App Developers Meet Medical Device Requirements?

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?
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2011年 9月 14日

FDA Mobile Apps Workshop: Getting a Handle on Clinical Decision Support Systems

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.
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