BIOE-2010 Study Guide - Final Guide: Postmarketing Surveillance, Substantial Equivalence, Medical Device
4 Apr 2016
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Document Summary
Adulterated & misbranded food, drinks, and drugs cannot be traded between states: animal model. New drugs must be proven safe before marketing. Extended fda authority from food and drugs to include medical devices. Fda regulates devices during development, testing, production, distribution, and use. Companies and manufacturers must register with fda and follow procedures for quality control. If it does not require premarket approval, they must meet performance standards. 3 classes (class i, class ii, class iii): each class has a different level of regulatory scrutiny based on risk. Now, fda requires facilities to report device malfunction leading to death, illness, or serious injury to fda and manufacturer (mdr: medical device reporting) Post market surveillance must be done by device manufacturer. Standardized test procedure-how they should be conducted: 1906: 1st. Fd&c passed with new amendments: 1976: medical. Effect of animal on implantation (ex. large: primates) Life expectancy and correlation with human aging skeletal maturity-rats.
