@CHAPTER{ iet:/content/books/10.1049/pbhe012e_ch3, keywords = {human security;public health threats;medical devices;Food and Drug Administration;US CFR;Code of Federal Regulations;public health protection;biological products;cosmetics;science-based information;tobacco products;food supply;veterinary drugs;FDA title 21;national counter-terrorism capability;}, title = {FDA title 21 of US CFR}, booktitle = Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification, publisher = {Institution of Engineering and Technology}, year = {2018}, pages = {31-42}, series = {Healthcare Technologies}, doi = {10.1049/PBHE012E_ch3}, url = {https://digital-library.theiet.org/;jsessionid=7afotatlim4k2.x-iet-live-01content/books/10.1049/pbhe012e_ch3} }