ABSTRACT
Regulations represent legal rules, established by government authorities, that dictate what procedures can be performed and how they should or should not be performed. In the case of tissue engineering, this can include how a biomaterial is fabricated, measured, and tested. Regulations are mandatory and legally obligatory, with penalties in place for any breaches, as determined by audits or legal investigations. In general, regulations normally apply to medical devices, rather than specific materials that contribute to their fabrication. Why do we need regulations? Basically, they have been put in place to protect the health and welfare of patients being treated in clinical settings, in this context, for tissue reconstruction strategies. Table 21.1 lists five most dominant regulatory authorities.
