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RE: IDE filing and timelines for approval

Posted by: , an hour ago

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Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous I agree with everything Richard posted, but I wanted to add some addition information. IDEs are approved/disapproved on the basis of safety read more
RE: Withdrawal of ISO 16142-1:2016 and ISO 16142-2:2017 - Essential Principles for Medical Devices and ...

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous May be superseded by the IMDRF documents - see App A? https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech- read more
RE: IDE filing and timelines for approval

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous I agree with Richard. It is 30 days. FDA can convert so you need another 30-day review, but that doesn't happen very often anymore. In a read more
Derivation of product requirements from regulatory information/standards - Best practice?

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hello dear colleagues, We are currently developing a process for transferring regulatory requirements from standards, regulations and guidelines read more
RA Consultant for Software in/as Medical Device

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Greetings! My small/mid-sized organization is interested in developing a software application for spatial tracking of a device (likely read more

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Timeliness of FDA decision to determine small business ...

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA ...
RA Consultant for Software in/as Medical Device

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Greetings! My small/mid-sized organization is interested in developing a software application for spatial tracking of a device (likely product code OLO ). As we have never developed such ...
Derivation of product requirements from regulatory ...

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello dear colleagues, We are currently developing a process for transferring regulatory requirements from standards, regulations and guidelines into product-related requirements. ...
Windsor Framework Regulation

By: Zornitsa Angelova , 5 hours ago

Posted in: Regulatory Open Forum

Dear Colleagues, I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation: Will the regulation require changing the testing and batch release activities currently performed in Ireland to Northern ...
New webinar posted for FDA Job Applications!

By: Kathy Loper , 7 hours ago

Posted in: Regulatory Open Forum

This is a great opportunity for those looking for positions within FDA and even those just wanting to spruce up their resume! DC/Baltimore Area Chapter Virtual Event: Tools and Tips To Enhance Your FDA Career Application| RAPS ------------------------------ ...