To “play” as a medical device company, you have to be willing to “pay” the entry fees involved. If you choose not to, there will be consequences. And eventually, you will pay. Paying later is NOT a good thing however.
So how do you have to pay to play in the medical device world? In the U.S., a medical device company needs to register with FDA and pay annual establishment registration fees. Further, if a medical device company submits a device for FDA review (such as a 510(k) submission), there are user fees required. These fees are pretty straight forward and the process is pretty well defined.
Keep in mind, though, there are other “fees” that must also be paid to play in the medical device industry. One of these other fees involves establishing your companies processes and procedures. Specifically, you need to be sure you are complying with Quality System Regulations defined in FDA 21 CFR part 820. This is not a trivial task but is very doable.
You also need to make sure your medical devices are properly registered with FDA, even if the products are class I devices and do not require a formal submission.
Can you sell your medical device without paying all these fees? I suppose technically the answer is yes. However, doing so opens you up to significant non-compliance risks and is in violation of FDA regulations. Keep in mind FDA regulations are federal laws. Keep in mind FDA investigators carry badges and are law enforcement officials. As a registered medical device establishment, you are subject to frequent FDA inspections. The inspections can happen unannounced.
Ignorance of FDA regulations is no excuse. Neglecting FDA regulations is even worse. If you want to play in the medical device market, then you made a commitment to follow the rules.