1. British Standards Institution. Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (ISO 13485:2016). London, United Kingdom: British Standards Institution; 2017.
2. Guidance document for premarket notification submissions for nitric oxide delivery apparatus, nitric oxide analyzer and nitrogen dioxide analyzer. Food and Drug Administration website; 2000. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073767.pdf. Accessed November 25, 2019.
3. Medical Device Single Audit Program: Frequently Asked Questions; 2017. Available from: https://www.fda.gov/downloads/medicaldevices/internationalprograms/mdsappilot/ucm430563.pdf. Accessed: February 13, 2019.
4. Medical Device Single Audit Program (MDSAP); 2018. Available from: https://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/. Accessed February 13, 2019.
5. Laaperi v. Sears, Roebuck & Co., Inc. 787 F.2d 726. 1986.