Бізнес · 08.11.20161 хв читання
Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
Локальний автоматичний переклад · Оригінальна мова джерела
Короткий зміст
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff." This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions.