Zdrowie i gospodarka · 28.08.1997
Convenience Kits Interim Regulatory Guidance; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Convenience Kits Interim Regulatory Guidance.'' The guidance is final and in effect at this time. This guidance applies to convenience kits and provides guidance regarding FDA's intent to exercise enforcement discretion with respect to premarket notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), and describes FDA's intent to propose rulemaking to exempt certain convenience kits from premarket notification requirements. The guidance addresses the type of data needed by the Center for Devices and Radiological Health (CDRH) to decrease the number of 510(k) submissions for convenience kits, saving Office of Device Evaluation (ODE) review resources. The agency is inviting public comment on this guidance.