对于医疗器械和化妆品,FDA要求生产商确保其产品在正常使用条件下的安全性,并符合FDA的规定和标准。医疗器械需要经过相应的分类和评估程序,并遵守医疗器械法规和标准,如Quality System Regulation(QSR)和医疗器械标记法规(Medical Device Labeling Regulations)。化妆品需要符合FDA对成分安全性和标签要求的规定。 因此,要确保...
Database (GUDID) for unambiguous and exhaustive device tagging. To help manufacturers meet staggered deadlines ofUDI compliance, FDA intends to publish final guidance onUDI Direct Marking, and draft guidance onUDI Convenience Kit,Use of Symbols in Labeling, andDefining the Unique Device Identifier(...
(d)Control numbermeans any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined. (e)设计历史文件Design history fil...
(d)Controlnumbermeansanydistinctivesymbols,suchasadistinctivecombinationofletters ornumbers,orboth,fromwhichthehistoryofthemanufacturing,packaging,labeling,and distributionofaunit,lot,orbatchoffinisheddevicescanbedetermined. (e)设计历史文件Designhistoryfile(DHF)。成品器械的设计历史记录的汇总。
Adam M. Masin
适用的FDA法规:软组织超声手术系统可能适用于不同的FDA法规,如医疗器械分类规则(Medical Device Classification Regulations)、医疗器械标记规定(Medical Device Labeling Regulations)等。 510(k)预先市场通知:如果软组织超声手术系统属于预先市场通知(510(k))类别的产品,制造商需要提交510(k)申请,以证明其与已获得FDA批...
FDA Issues Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device PromotionNo other daily resource has the exclusive... KA Barritt 被引量: 0发表: 0年 加载更多研究点推荐 Medical Device Patient Labeling 站内活动 ...
答:PIV的注册过程需要遵守FDA的相关法规,如21 CFR Part 820 - Quality SystemRegulation和21 CFR Part 807 - Medical Device Labeling等。 问:PIV的FDA认证周期一般需要多久? 答:一般情况下,PIV的FDA认证周期约为3-6个月左右,具体时间根据产品类型、注册流程的复杂性和文件完整性而有所不同。
二、对标产品(Predicate Device) 2.1 对标产品的定义 FDA将Predicate Device定义为已合法上市的器械,该器械在1976年5月28日之前合上市(预修订器械),并且不需要PMA;或已从III类重新分类为II类或I类;或已经发现通过510(k)过程基本上是等效的。 2.2 如何选择对标产品?
preventive action. Subpart K--Labeling and Packaging Control § 820.120 - Device labeling. § 820.130 - Device packaging. Subpart L--Handling, Storage, Distribution, and Installation § 820.140 - Handling. § 820.150 - Storage. § 820.160 - Distribution. § 820.170 - Installation. Subpart M--...