Guidance for Industry and Food and Drug Administration Staff; Premarket Approval Application Modular Review; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Premarket Approval Application Modular Review." This guidance document is intended to provide industry and FDA staff with information regarding the premarket approval application (PMA) modular review program. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).