AMA on Combination Products

  • 27 May 2022
  • 2 replies

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We invited Shannon Hoste from Agilis for an exclusive AMA (ask me anything) session to talk Combination Products.

If you have run into problems, send a message directly to @Etienne and let us know!

2 replies

In a past life, our combo device was a silver containing wound dressing. We really struggled around how to address section 211.103- Calculation of yield. Would love to hear how companies address this section when they aren’t a more traditional combo device! 

I read that the FDA does not accept MDSAP for combination products but that they might reduce the inspection scope. I would love to hear if anyone has experience with the scope of inspections for combination products that exceed those of MDSAP (ISO 13485) and how that influences the FDA inspections if you do have a MDSAP certification?