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https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/UCM593521.pdf
. Accessed 17 Apr 2018.
2. Code of Federal Regulations Title 21 CFR 860.7.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7
. Accessed on 18 Apr 2018.
3. Medical Device User Fee Amendments (MDUFA)
https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/default.htm
. Accessed on 14 Aug 2018.
4. The Product Code Classification Database.
https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database
. Accessed on 19 Apr 2019.
5. FDA 510(k) premarket notification.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161043
. Accessed on 19 Apr 2019.