AMA on Regulatory Strategy


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This week we’ve invited Michelle Lott from LeanRAQA for an exclusive AMA (ask me anything) session with the community concerning the topic of anything related to your Regulatory Strategy!

If you have any feedback or suggestions, send a message directly to @Etienne and let us know!


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We are developing a drug delivery device to be used in combination with pharmaceutical companies. The drug is the PMOA, and the device could be used with many different types of drugs, kind of like a new type of syringe.

Our original plan was to target new drugs and to be cross-labeled as part of their submission. The reason we wanted to do that instead of doing the De Novo pathway was so that no one would be able to follow us to market. 

What regulatory strategy do you recommend for this type of device?

We’re developing a me-too product and have a couple solid predicate devices to use as the basis for our 510k. It’s a debate amongst team members here whether we should follow in their footsteps to the letter, or how much wiggle room is there in the regulatory requirements for our device vs. the currently marketed device? As an example, if a regulatory test is listed in their 510k summary (biocompatability to ISO 10993), but we’ve characterized the materials used in our device to have little to no impact on biocompatability, should we submit for biocomp testing anyway because our predicate device has gone that direction?

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I’ve heard some companies are dropping their CE mark due to EUMDR. Do you see similar issues with EU IVDR?

Couldn’t locate a link to the webinar. Not a great setup. I’m out.

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There is no link to join this...

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There is no link to join this...

Thanks for the heads up! 

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Couldn’t locate a link to the webinar. Not a great setup. I’m out.

I appreciate the feedback - we’ll build out links to future AMA’s (that’s our initial preventive part of this CAPA anyway...)

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We are developing a drug delivery device to be used in combination with pharmaceutical companies. The drug is the PMOA, and the device could be used with many different types of drugs, kind of like a new type of syringe.

Our original plan was to target new drugs and to be cross-labeled as part of their submission. The reason we wanted to do that instead of doing the De Novo pathway was so that no one would be able to follow us to market. 

What regulatory strategy do you recommend for this type of device?

Hey @SilasOsborn see minute 1:15 in the video above for your answer!

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We’re developing a me-too product and have a couple solid predicate devices to use as the basis for our 510k. It’s a debate amongst team members here whether we should follow in their footsteps to the letter, or how much wiggle room is there in the regulatory requirements for our device vs. the currently marketed device? As an example, if a regulatory test is listed in their 510k summary (biocompatability to ISO 10993), but we’ve characterized the materials used in our device to have little to no impact on biocompatability, should we submit for biocomp testing anyway because our predicate device has gone that direction?

Hey @ScottVH see minute 3:30 in the video above for your answer! Thanks!

See the attachments.

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See the attachments.

Hey @Jaymie Hu, can you provide some context around your docs?

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