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  • 1) The DIBD is the date that the active substance was first cleared for clinical investigation by a regulatory authority. So, if first cleared by FDA then it would be the "primary" IND. 2) Since the DSUR will cover all INDs, which I assume are for different dosage forms and/or indications, the DSUR should be submitted to all INDs that include the active ...

  • There is no such database that exists currently - in the future this information will be available via EUDAMED.  I highly doubt ISS to provide you information verify CE Certificates issued by them - I have never had a Notified Body provide this information, in particular about another company. ------------------------------ Richard Vincins RAC Vice ...

  • Don't pay attention to the European Harmonised Standards list - always use the most current version of the standard.  The harmonised standard list is dreadfully out of date, missing information, and obsolete.  To comply with Good Manufacturing Practices (GMP) and state of the art related to processes and application of regulations, standards, or guidance, ...

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    RE: RAC US Exam

    I passed the US RAC exam in Spring 2019 and do not feel attempting to review  all or even most of the FDA guidance documents would be a good use of your time. I would focus on the regulations and law; use guidance documents where clarity is needed to fully comprehend a subject area. I can't think of a single question that directly related to (only) ...

  • Many regulatory agencies have a total life cycle approach to medical devices, including End of Life (EoL) for devices that must be maintained for some period of time.  This is more prominent in US and EU especially under the new EU MDR, but FDA definitely expects life cycle management of a device.  Is there a specific regulation? Not really, but there ...


Volunteer Appreciation 2019

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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