So you’ve done your homework and confirmed that your device must go through the 510(k) process. You know the classification, three-letter product code, and the regulation number, and you’ve done an exhaustive review of summary documents for competing devices. You have chosen your predicate ...
美国是最早提出对医疗器械实行分类管理的国家之一,根据FD&CA513,FDA按照医疗器械的安全性和有效性,将医疗器械分为三类,但是无论I 、II、III器械首先企业都需进行企业注册与产品登记(Enterprise Registration and Product Listing)。 I 类器械 这类器械实施一般控制(General Control),指危险性小或基本无危险性产品,例如...
Final rule for De Novo classification process First, FDA has published a final rule for the agency’s De Novo classification process whereby manufacturers of innovative devices may obtain US market authorization . Effective January 3, 2022, the final rule includes a new section, S...
A third option is the Product Development Protocol. It follows a similar vein of substantial equivalence that we saw in the 510(k) submission process, and it's for companies bringing a device to market that uses technology already widely established and understood. A PDP maps out in advance t...
rule states, in part, that the degree of risk to the patient associated with the use of IHC products depends on whether the product is used as an adjunct to conventional histopathology diagnostic techniques or provides information that is used independent of the conventional diagnostic process. The...
A.The firm’s investigation process is deficient in that the firm does not require identification of particulates found during the visual inspection process. B.The firm’s visual inspection process governed by SOP ILP-001-W “Product Inspection and Defect Classification” effective 2/22/2023 is de...
The 510 (k) clearance route is less time consuming, expensive and generally less burdensome than going through the entire PMA process, which is why it is a method of regulation reserved for lower-risk devices. What are the required contents of the 510 (k) submission? The 510(k) may be...
Random House Kernerman Webster's College Dictionary, © 2010 K Dictionaries Ltd. Copyright 2005, 1997, 1991 by Random House, Inc. All rights reserved. ThesaurusAntonymsRelated WordsSynonymsLegend: Switch tonew thesaurus Noun1. FDA- a federal agency in the Department of Health and Human Services...
the process results in the production of acceptable product. Successful completion of the initial conformance batches would normally be expected before commercial distribution begins, but some possible exceptions are described in the CPG. For example, although the CPG does not specifically mention concurre...
Furthermore, predicate devices no longer were limited to products already on the market prior to May 1976 but could include devices cleared through the 510(k) or PMA process. In recent years, the FDA has used the 510(k) provision as the dominant mechanism for new device clearance, reviewing...