The FDA is Recommending Transition to New Duodenoscopes

USA – The FDA is Recommending Transition to New Duodenoscopes

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

USA – US FDA recognizes latest edition of ISO 14971 as medical device consensus...

The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for...
FDA Finalizes Guidance on Annual Reports for Approved PMAs

USA – FDA Finalizes Guidance on Annual Reports for Approved PMAs

The US Food and Drug Administration (FDA) last month altered and finalized a 2014 draft guidance explaining what information needs to be provided in...
CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

USA – CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

The US Food and Drug Administration (FDA) on Friday released new draft guidance to help clarify the agency’s premarket submission recommendations for percutaneous transluminal...
US FDA issues updates to classification regulations, hires verification services

USA – US FDA issues updates to classification regulations, hires verification services

The US Food and Drug Administration published two final orders pertaining to device classifications and pathways to market. Additionally, it announced a new contract...
US FDA issues updates to classification regulations, hires verification services

USA – Industry, doctors, patients diverge on FDA outline for breast implant labels

Some in the device industry are pushing back against proposed FDA label changes to breast implants, including an acknowledgement of "breast implant illness" and a...
10 Medical Devices Recently Approved by FDA

USA – 10 Medical Devices Recently Approved by FDA

From companion diagnostic tests to ear tubes for children and adults suffering from repeated ear infections, FDA reviewers stayed busy in the final months...
FDA publishes final list of 510(k)-exempt devices

USA – FDA publishes final list of 510(k)-exempt devices

The FDA today published a list of Class I and Class II medical devices that it now considers exempt from premarket notification, in accordance...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – Institutional Review Board (IRB) submissions: Necessary for usability tests?

An IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. An...
Study: Speedier reviews might have compromised rigor of FDA approval

USA – FDA issues draft guidance on communications with combo product developers

The 21st Century Cures Act requires FDA to provide final guidance on aspects of the submission process including how companies should obtain feedback from...

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