This draft guidance is intended to describe the Food and Drug Administration’s (FDA or Agency) current thinking about how manufacturers and distributors (firms) of prescription human and animal drug products (drugs) and medical devices (devices) can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or [...]
Draft Guidance – CDRH Appeals Processes
Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action; petitions; and hearings. These processes are broadly described in FDA regulations. This draft document provides general [...]
The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications – Final Guidance
This document provides guidance to the regulated industry and reviewers on two alternative approaches that may be used, under appropriate circumstances, to demonstrate substantial equivalence. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm
Draft Guidance – Medical Device Classification Product Codes
The purpose of this guidance document is to educate regulated industry and FDA Staff on how, when and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm285317.htm?source=govdelivery
