Class I Medical Device Should have a DHF

If you are developing a class I medical device, you could make a solid argument for not documenting Design Controls and not maintaining a Design History File (DHF). In fact, your argument would be supported directly by FDA Design Control regulations. Very few class I devices even require Design Controls per FDA.

However, if this is the approach you decided to take, I would advise against this. You might argue that documenting Design Controls will only slow you down on your process to bring your class I device to the market. Perhaps.

So why do I recommend documenting Design Controls and maintaining a DHF for your class I medical device?

Design Controls are documented, objective evidence that the product development process has been followed. Design Controls help ensure that User Needs are translated into Design Inputs. That Design Inputs result in drawings, specifications, etc. (Design Outputs). That Design Verification demonstrates the Design Outputs meet Design Inputs. That Design Validation demonstrates the User Needs have been addressed. That the product design was reviewed throughout (Design Review) to ensure the product design is safe and effective. That the product design has been transferred to production (Design Transfer).

Design Controls are proof that you designed the right product, that your product is safe for its intended use, and that your product can be manufactured.

Yes, Design Control documentation and records do take some effort, and time. And if you think it’s worth it to shave a little bit of time in order to get to market faster, this is your choice. As noted, FDA does not require you to document Design Controls for your class I (unless your device is on the special class I devices requiring Design Controls).

But what will happen after you launch? What happens when the product needs to be changed? What happens if you receive a customer complaint?

Okay, Design Controls does not prevent these things from happening completely. But Design Controls, provided you follow the premise and intent rather than just satisfying a checkbox, are intended to find issues during the product development process before being manufactured and used.


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