Good Manufacturing Practices (GMP) on FDA regulatory agenda
This article was originally published in Clinica
Executive Summary
The final revised US GMPs for medical devices are due to be published in September this year, according to the FDA regulatory agenda. Other outstanding regulations to implement the 1990 Safe Medical Devices Act which will be introduced in the next five months include: procedures for a hearing before imposition of civil money penalties; premarket review exemption for humanitarian devices; procedures for using the FDA's device recall authority; requirement for healthcare facilities and distributors to report deaths and serious injuries/illnesses related to devices; procedures for manufacturers to report to the FDA health-related removals and corrections of devices; and procedures for temporary suspension of a PMA application.