US FDA explains how it deals with 'requests for information' on device classification

摘要

The US Food and Drug Administration has issued two guidelines explaining the agency's procedures for dealing with requests from device companies seeking information on the risk classification level of their products and the user fee associated with such applications.Such requests, also called 5l3(g) submissions, allow device companies to obtain the agency's view on the classification and regulatory requirements that may be applicable to a particular device.The first guideline describes the FDA's procedures for accepting, reviewing and responding to 5 13(g) requests.The document clarifies that the agency's response to 5 I 3(g) requests for information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the Federal Food, Drug, and Cosmetic Act.The second guideline, issued in a question-answer format, describes the user fees associated with 513(g) requests. For fiscal year 2012, the standard fee for such requests is $3,462. For small business entities, the fee is $1,731.