AMA on Special Controls

  • 18 May 2022
  • 7 replies
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This week we’ve invited Mike Drues from Vascular Sciences for an exclusive AMA (ask me anything) session with the community concerning the topic of the FDA’s Special Controls.

If you’re not signed up yet, be sure and RSVP here.

What challenges are you currently face as you prepare your products submission? What feels unclear?

Ask us anything!

Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.

P.S. There is an interactive video element to this AMA that you can participate in. Click HERE to join the Zoom meeting to listen live as Mike answers the questions posted below.

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


7 replies

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If I’m understanding how this works, if we pursue a De Novo pathway we would also be responsible (or “privileged”) to put Special Controls in place for future predicates attempting to follow us to market.

In that event, how do companies determine what Special Controls to put in place? Does the FDA compare the special controls that the De Novo company presents with other “similar” devices?

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I’m sorry I won’t be there in person - big fan of the podcast though!

Are special controls ever “repealed” or altered? Or if a device came along that didn’t need those special controls because some new way of achieving the expected function, is that automatically a De Novo and a new product code? ]

It seems like there should be some function for removing old tech from the market that is no longer state of the art. Or at least impose some of the newer special controls.

Hopefully that makes sense, interested in your answer. Thank you!

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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. We’re new to combination products, however, and so I’m not exactly sure how this would work. 

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

Userlevel 2

I don’t have anything on special controls but I’ve heard you talk about “pushing back” on the FDA and I wonder how well that really works? What does that actually look like in real life and how often does that turn out in a companies favor?

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When we were preparing our design controls matrix for our pump, our regulatory people said we should collect all data around our EPRs (essential performance requirements) so that the agency would be “overwhelmed” with data. It’s true that we collected some of this data when we were doing other tests, but it just seemed like a lot of tedious extra work to document for sample sizes outside our specified verification plan. 

Is this something you see or recommend?

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How important is it to have the whole picture of our product in the market? Some things, like reimbursement, and certain aspects of manufacturing, are still being sorted out.

We know we have a solution to an unmet need, but do we have to detail out our product positioning in the submission document?

Userlevel 2

I thought of something else. I’ve heard you say something about not being a fan of 510k, or the predicate/equivalent concept (that was my understanding, forgive me if I’m mistaken.)

I’m curious how you would set things up, given the opportunity? Would there be no predicate system, and every device be something of a De Novo?

Love to hear what your vision would look like.

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