美国FDA指导原则 Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints.docxVIP

Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email \o Print this page Print This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s. GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR PROTECTIVE RESTRAINTS GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR PROTECTIVE RESTRAINTS GENERAL HOSPITAL DEVICES BRANCH DIVISION OF DENTAL, INFECTION CONTROL AND GENERAL HOSPITAL DEVICES OFFICE OF DEVICE EVALUATION DECEMBER 1995 This guidance does not create or confer any rights, privileges, or benefits for or on any person, nor does it operate to bind FDA or any other person. The agency will consider individual circumstances on a case-by-case basis. TABLE OF CONTENTS I. INTRODUCTORY INFORMATION A. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 B. Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 C. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . .2 D. Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . .2 E. General Principles Regarding Presentation of Data . . . . . . .3 F. Supplementary Guidance. . . . . . . . . . . . . . . . . . . . .4 G. The Review Process. . . . . . . . . . . . . . . . . . . . . . .5 H. Sta