FDA 510K 申报服务和周期（含工厂注册和合同范围内产品列名）
FDA De Novo
FDA MD 预提交（Pre-submission）申报服务和周期
Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance en[title]d ``Qualification of Medical Device Development Tools (MDDT).'' This document formalizes the MDDT program and provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. In addition, the guidance discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. FDA considered comments on the draft guidance and revised the guidance as appropriate.
MDDT is a scientifically validated tool that aids device development and regulatory evaluation. The guidance describes the framework and process for the voluntary CDRH qualification of MDDT, including definitions of applicable terms, criteria for evaluating a MDDT for a specific context of use, the threshold for qualification, and the contents of a qualification submission.
The intent of this voluntary qualification policy is to: (1) Enable faster, more efficient development of important life-saving and health promoting medical devices, (2) promote the development of tools to facilitate more timely device evaluation, (3) provide a mechanism to better leverage advances in regulatory science, and (4) more quickly and more clearly communicate with CDRH stakeholders about important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation. CDRH expects the qualification process to expedite development of publicly available tools, which could potentially be used widely in multiple device development programs.
The intent of this voluntary MDDT program is to promote the development and use of tools to streamline device development and evaluation. Once an MDDT is submitted in accordance with the FDA guidance en[title]d ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' (Ref. 1) and qualified for a specific context of use, it can be used by any medical device sponsor for that context of use. MDDTs can be used for the qualified context of use without the need to reconfirm the suitability and utility of the MDDT when used in a premarket submission. Qualification may contribute to acceptance and application of MDDTs across multiple medical device development programs. Qualified MDDTs can be utilized by many sponsors to aid in optimizing device development and evaluation.
As discussed in the November 14, 2013, Federal Register notice (78 FR 68459), FDA announced the availability of the draft of this guidance and interested persons were invited to comment by February 12, 2014. In the August 15, 2014, Federal Register notice (79 FR 48170), FDA began accepting nominations for participation in the voluntary MDDT Pilot Program. FDA reviewed and considered all public comments received and revised this guidance as appropriate.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Qualification of Medical Device Development Tools.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866