Subsequent product code
2019年11月13日 — ... subsequent applicants of generic drug products can perform a 6-month study at the accelerated storage condition only. Long-term stability ... ,2009年7月3日 — Product Code is a primary code, while subsequent product code is a secondary code, for additional feature(s) that predicate devices of the ...
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Subsequent product code 相關參考資料
Adding a second and subsequent aibo products ...
The following describes how to add a second and subsequent aibo products of yours. ... Alternatively, you can enter the 12-digit alphanumeric code printed on the ... https://helpguide.sony.net Center for Drug Evaluation, Taiwan
2019年11月13日 — ... subsequent applicants of generic drug products can perform a 6-month study at the accelerated storage condition only. Long-term stability ... https://www.cde.org.tw Classification of the medical device code and 'subsequent' ...
2009年7月3日 — Product Code is a primary code, while subsequent product code is a secondary code, for additional feature(s) that predicate devices of the ... https://elsmar.com FDA issues guidance on medical device product codes
2013年4月17日 — The classification product code helps the FDA import entry reviewer determine what information should be verified to ensure the medical device ... https://www.lexology.com FDA Product Code Classification
This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product ... https://www.nber.org Medical Device Classification Product Codes
2015年5月21日 — Multiple subsequent product codes can be used even if they fall under a different regulation and class. If multiple product codes are assigned ... https://www.fda.gov Medical Device Classification Product Codes Guidance for ...
2013年4月11日 — Multiple subsequent product codes can be used even if they fall under a different regulation and class. If multiple product codes are ... https://www.fda.gov US-FDA-Device-Classification-white-paper. ...
The FDA1 currently has approximately 6,500 product codes assigned that reside within the different Device Classification · Panels found in Parts 862-892 of the ... https://www.emergobyul.com Use of Recalled Devices in New Device Authorizations ...
由 KT Kadakia 著作 · 2023 · 被引用 14 次 — We used the Devices@FDA database to identify 510(k) devices authorized within 12 months of a recalled device and with the same product code. https://jamanetwork.com 美國高風險醫療器材的上市送件流程
FDA指引建議,如果不清楚某一分類之醫療器材是否需要PMA,. 可以使用“Product code”搜尋PMA 和510(k)數據資料庫,參考是否與已獲得通過的器. 材實質等同,如果在510(k)數據 ... https://www.cde.org.tw |