Answer:
True.
Step-by-step explanation:
FDA is acronym for Food and Drug Administration (FDA). It is a federal agency of the government of the United States of America saddled with the responsibility of protecting the consumers of edible products and public health safety.
Basically, FDA was established essentially as a consumer protection agency and as such they ensure all goods that are to be sold to consumers for personal use are in tandem with standard health and safety requirements.
Hence, all complex medical devices must be proven safe before the Food and Drug Administration (FDA) will allow them to be sold in the United States of America.