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RE: IND Module 3 versioning?

Posted by: Mark De Rosch, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Technically, i guess, the documents get versioned (from FDA's perspective) as part of the sequence in which the documents are submitted. However, for internal reasons, I typically include a month and year read more
RE: IND Module 3 versioning?

Posted by: Arvilla Trag, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Good morning, Anonymous. I do a lot of late-stage Module 3 writing, and it is my practice to reject any document that is not signed and dated. This goes directly to data integrity: attributable, legible, read more
RE: Supplier Quality Audit Template

Posted by: Arvilla Trag, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Good morning, Anonymous. Unfortunately, I do not have a medical device supplier audit template to offer you. But I do have the attached white paper which outlines quality requirements you are expected read more
RE: Critical Parts/Components - Critical Suppliers

Posted by: Richard Vincins, 5 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Anon, This is a "must do" exercise medical device manufacturers need to go through and there can be many different ways to do this. It can be from having a couple check boxes on a component specification, read more
RE: Drop Ship Medical Device in Europe, even though we are a US Company

Posted by: Richard Vincins, 5 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Good day Anon, Without seeing the exact shipping path and transactions occurring - based on the information provided, yes this is ok. In fact, shipping products within the European Union is quite ok read more

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Posted in: Regulatory Open Forum

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Unofficial Medical Device Study Group

By: Karen Underwood , 22 hours ago

Posted in: Regulatory Open Forum

Hi Everyone Just a reminder we will meet this week at 3 pm to 4 pm on Friday. I will present Chapter 8 of EU, from the 5th edition of the RAPS Study Guide. Join Zoom Meeting https://umaryland.zoom.us/j/96213811970?pwd=V2lQeWowQTAxaDc2U2lpU0h3dVZ4dz09 ...
Dear Dr Letter

By: Anonymous Member , 16 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous We plan to send out a Dear Dr Letter to notify investigators of a new safety event for our investigational drug. Do we need to submit this Dear Dr. Letter to FDA for review first before sending ...
Managing The Company's Expectations for 510(k) Cle ...

By: Nancy Singer , yesterday

Posted in: Regulatory Open Forum

You are making a presentation to the senior management team. You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a ...
Lebanon Medical device regulations

By: Sushma Polisetty , yesterday

Posted in: Regulatory Open Forum

Hi RAPS Members, Am struggling with lebanon main regulation which i have to look for for medical devices, please help. i am getting info. little bit from 3rd party sources only. only 1 official document found i.e Resolution No. 1/455 Regulating ...