Did you know that Design Controls were the #1 issue cited by FDA during 2013?Of the 4000+ 483 investigational observations issued by FDA during FY2013, nearly 600 of the 483s pertain to Design Controls.
As you probably know, FDA Design Controls regulations are covered in 21 CFR part 820.30.
Design Controls are broken down even further as follows (with total number FY2013 FDA 483s issued in parentheses).
When you evaluate the details of FY2013 FDA 483s issued for Design Controls, you will notice a few recurring themes:
Bottom Line: Medical device companies are not doing a good job of addressing Design Controls.
Why is this? FDA Design Controls regulations have been in place since 1997.
Isn't this enough time for the medical device industry to embrace and understand Design Controls?
FDA has a decent guidance document on Design Controls. Does this guidance help? Are medical device companies aware of this?
I've been in the medical device industry since 1998 and closely associated with product development and Design Controls throughout my entire career.
From my personal experience on the topic, here are some things I've observed:
Jon is the founder of Greenlight Guru (the leading cloud-based platform purpose-built for MedTech companies) and a medical device guru with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help...