FDA issues new draft guidance on medical device product codesJonathan S. KahanLina R. Kontos
1. NDC/NHRIC labeler codes for medical devices: The FDA is no longer issuing new FDA labeler codes to device manufacturers. The FDA labeler codes are necessary to develop NDCs (National Drug Codes) – for the purpose of identifying drugs. The application of FDA labeler codes and NDCs/NHRICs...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff 其中所提及的 pre-amendments device定义如下: The term "preamendments device" refers to devices legally marketed in the U.S. by ...
• Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff • Assay Migration Studies for In Vitro Diagnostic Devices • Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff • Investigational Device Exemptions...
Food and Drug Administration (FDA) which informs medical device industry about the intention t... G Slabodkin - 《Healthdatamanagement Com》 被引量: 0发表: 2014年 FDA issues new draft guidance on medical device product codes The article reports on the draft guidance issued by the U.S. ...
FDA Product Codes
Final FDA guidance on Unique Device Identifier (UDI) rules for medical devices and stand-alone software comes several years after draft guidance issued. Learn more at Emergo by UL.
6 Contains Nonbinding Recommendations • Standards-based data repository with controlled vocabularies including: o Dun Bradstreet (DB) Number (DUNS)11 o Global Medical Device Nomenclature (GMDN)12 o FDA Product Codes • Free and public access to the device information in GUDID via public search...
6、imulator 生物体刺激器 bionic knee 仿生膝关节 biopharma: biopharmaceutical products 生物药物产品 bipolar 双相燥郁症 birth defect 出生缺陷, 新生儿缺陷, 先天缺陷 BLA = biologic license application 生物制品许可申请 blank control 空白对照 blend uniformity analysis 混合均匀度分析 blind 盲法 blind codes 编...
(FDA) implemented a new device problem codes in July 2009.In this paper, we presented an overview of the device problem codes and their structure, demonstrated device problemcodes' practical significance to medical device risk assessment using the Manufacturer and User Facility Device Experience(MAUDE...