Home Free?.....Not So Fast

Click on image to enlarge

While 510k is exempt GMP (Good Manufacturing Practices) regulatory requirement under 21 CFR 820 is not exempt and still need to be fully complied with. 

GMP

https://en.wikipedia.org/wiki/Good_manufacturing_practice

GMP Regulations

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Remember I am not a lawyer but I hold an honorary JD from the University of Street Smart Chicago.