FDA

7 Clues You are Innovating a Medical Device

Rainbow Heart

Having a controlled Design and Development process is very important to the FDA and showing evidence of it is critical to your submission for clearance or approval.  So of course the earlier you know whether your amazing product or idea is  a medical device, the easier it will be to navigate the process and be in compliance. Even more, nobody wants to go back through years of documents and piece them into an acceptable submission. In the words of Sweet Brown, "Ain't nobody got time for that."

So because I care about your sanity and time, I have a list of questions to help determine whether your burgeoning product or idea is indeed a medical device. 

DOES YOUR TECHNOLOGY:

  1.  diagnose a disease, ailment, or abnormality?
    • ex. ultrasound
  2.  cure a disease or ailment?
    • artificial hip to replacement 
  3. mitigate the impact or improve the outcome of a disease?
    • ex. neurostimulator to reduce epileptic seizures
  4. treat or is used in the course of treatment of a disease?
    • ex. oxygen tank to treat COPD
  5. prevent a disease or ailment?
    • ex. glucose monitor to prevent diabetic coma/sugar spikes
  6. affect the structure or function of the body 
    • ex. heart stent
  7. have recognition in the official National Formulary,  US Pharmacopoeia, or supplement thereof?

If you answered yes to any of these questions, it is a huge possibility your technology or idea will be a medical device and I see an FDA audit in your future.

Points of Note

  • The criteria listed above apply to both man and beast - so if you are planning on creating a device for animals you too will have a blossoming relationship with the FDA
  • I purposely used the term product, idea, or technology in reference to a medical device because medical devices are taking on many forms: software, mobile applications, instruments, machine, etc. 
  • This is not an all inclusive or exhaustive list, so do not hesitate to contact me and we can chat about your specific instance.

More information on this topic can be found on the Food and Drug Administration website under the heading What is a Medical Device?

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