Guidance for Industry and FDA Staff
Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices
Document issued on: May 11, 2005
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This document superdes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 29, 1998, and Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, issued January 13, 1997.芜湖方特水上乐园
For questions regarding this document concerning devices regulated by CDRH contact Linda Shoemaker at (240) 276-4055. For questions regarding this document concerning devices regulated by CBER contact Linda Weir at (301) 827-6136.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Office of In Vitro Diagnostics
Center for Biologics Evaluation and Rearch
Office of Blood Rearch and Review
Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, plea refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revid or updated.
Additional Copies
CDRH
Additional copies are available from the Internet
at:v/cdrh/ode/guidance/337.pdf, or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the cond voice prompt, press 1 to order a
document. Enter the document number (337) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
CBER
Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at
v/cber/guidelines.htm.
Table of Contents
Introduction (1)
The Least Burdensome Approach (1)
Scope (2)
Relationship to Other Documents (3)
Terminology (3)
Level of Concern (4)
Determining Level of Concern (6)
Software-related Documentation (8)
The Special 510(k) Program (15)
The Abbreviated 510(k) Program (16)
Additional Topics (17)
二年级数学题目References (19)
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in
司马德宗Medical Devices
This guidance reprents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can u an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction
This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-bad devices that incorporate software. This document is a result of ongoing efforts to state our recommendations more clearly and ensure they remain current as technology advances. This document also combines into one guidance recommendations previously included in two guidance documents.i
The Least Burdensome Approach
四面都是山The issues identified in this guidance document reprent tho that we believe should be addresd before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues prented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the guidance, A
Suggested Approach to Resolving Least Burdensome Issues, v/cdrh/modact/leastburdensome.html.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The u of the word should in Agency guidances means that something is suggested or recommended, but not required.
Scope
For the purpos of this document, we refer to devices that contain one or more software components, parts, or accessories, or are compod solely of software as “software devices,” including:
•firmware and other means for software-bad control of medical devices
般若波罗蜜心经全文•stand-alone software applications
•software intended for installation in general-purpo computers
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•dedicated hardware/software medical devices.
•accessories to medical devices when tho accessories contain or are compod of software.
This guidance applies to software devices regardless of the means by which the software is delivered to the end ur, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.
Software not covered by this guidance includes software designed for manufacturing or other process-control functions but not intended for u as a device. For further information or to clarify the requirements for your device, plea contact the responsible FDA review division.
This guidance document applies to all types of premarket submissions for software devices, including:
路由器重新设置•Premarket Notification (510(k)) including Traditional, Special, and Abbreviated submissions •Premarket Approval Application (PMA)
•Investigational Device Exemption (IDE)
•Humanitarian Device Exemption (HDE), including amendments and supplements.
