Orthopedic fracture fixation plates: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval Equipment Safety Fracture Fixation Orthopedic Fixation Devices -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance provides performance criteria for Orthopedic Fracture Fixation Plates in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (11 pages)).
- NLM Unique ID:
- 9918452387606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452387606676