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RE: Usability Engineering and HFE for an Established MD

Posted by: Jonathan Amaya-Hodges, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

I'm addition to the good advice that has already been provided, in this situation I'd also encourage you to review the recent draft guidance from FDA which provides FDA's thinking on what type of HF data read more
RE: Tell us about yourself

Posted by: Anuroop Yenumala, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi John, Thank you for initiating this discussion thread. It's incredibly valuable to connect with individuals who have more experience in the field. To give you a bit of background about myself, I hold read more
RE: Best practices and possible outcomes for FDA inspections

Posted by: Richard Vincins, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Anon, Indeed the questions being asked are quite broad and might want to seek some specific training or obtain expert support. Typically foreign establishment inspections by US FDA are notified read more
RE: IDE filing and timelines for approval

Posted by: Richard Vincins, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Anon, You can get information concerning the IDE process here: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process. Basically an IDE is approved at Day read more
RE: EU MDR Application submission Deadline

Posted by: Johan Custers, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Dear Anon, I agree with the other responses here, you need to move fast. Mr. Christingers flowchart explains the situation for legacy devices beautifully, thank you for your work there, mr. Christinger! read more

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Ranging study requirement for parenteral ANDA

By: Prashant Kshirsagar , 6 hours ago

Posted in: Regulatory Open Forum

Dear All, We are developing parenteral solution for injection with generic buffer, and require information about the requirement of the ranging (excipients ranging study) for the parenteral ANDA. Could you please help us with this? Thanks ...
Indian Government Announces a New Ethical Program for ...

By: Ames Gross , 9 hours ago

Posted in: Regulatory Open Forum

On March 12, the Indian Department of Pharmaceuticals issued a new regulation for drug marketing called the – Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Accordingly, all pharmaceutical associations in India are required to set up ...

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ICYMI: Driving Sustainability initiatives through the ...

By: Hasnaa FATEHI , 11 hours ago

Posted in: Regulatory Open Forum

Link to register: https://www.raps.org/events/western-canada-chapter-virtual-event-driving-sustainability-initiatives-through-the-healthcare-system ------------------------------ Hasnaa FATEHI MedTech Regulatory and Quality Assurance QARALogic Vancouver ...
Accesso alle tempistiche prolungate per la transizione ...

By: Stefano Adami , yesterday

Posted in: Italy Local Networking Group

Manca poco più di un mese al 26 maggio 2024! Si tratta del termine ultimo per la transizione al regolamento sui dispositivi medici (MDR) 2017/745. Ecco cosa fare: Valutare il proprio portafoglio : Valutare quali prodotti sono interessati ...
Rules and procedures for export and approval of use ...

By: Anonymous Member , 21 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous What are the current rules and procedures for export of medical devices to Vietnam and approval of their use by physicians/dentist? Can you provide more details/links/best practices for this ...