STEP2: 获取得邓白氏码 邓白氏码(D-U-N-S Number)是一种实时动态的企业身份标识,它源自于邓白氏所拥有的9位数字全球编码系统,相当于企业的身份识别码,可以帮助识别和讯速定位全球超过4亿家企业的信息。如企业(制造商、进口商)未申请邓白氏码,则需要通过代理商进行申请。邓白氏码是一企一码。 STEP3: 确认UDI的产...
STEP2: 获取得邓白氏码 邓白氏码(D-U-N-S Number)是一种实时动态的企业身份标识,它源自于邓白氏所拥有的9位数字全球编码系统,相当于企业的身份识别码,可以帮助识别和讯速定位全球超过4亿家企业的信息。如企业(制造商、进口商)未申请邓白氏码,则需要通过代理商进行申请。邓白氏码是一企一码。 STEP3: 确认UDI的产...
STEP2: 获取邓白氏码 邓白氏码(D-U-N-S Number)是一种实时动态的企业身份标识,它源自于邓白氏所拥有的9位数字全球编码系统,相当于企业的身份识别码,可以帮助识别和讯速定位全球超过4亿家企业的信息。如企业(制造商、进口商)未申请邓白氏码,则需要通过代理商进行申请。邓白氏码是一企一码。 STEP3: 确认UDI的产品...
Appendix 1 – Medical Device User Fee Cover Sheet number that is located in the upper right-hand corner, beginning with the letters MD. This number will assist FDA in tracking your payment and submission for the review process. Submitting Payment Please send a printed copy of the completed Cov...
However, this category had the highest number of units recalled—57 254 133—with almost all units from the recall being 1 contact lens solution (COMPLETE MoisturePLUS multi-purpose contact lens solution; Advanced Medical Optics Inc, Santa Ana, California).10 This lens solution was recalled when...
FDA ESTABLISHMENT IDENTIFIER (FEI) NUMBER An FDA Establishment Identifier (FEI) Number is issued to track inspections of regulated medical device or drug establishments. FEI numbers are also used to track establishments user fee payments. Unlike the FDA Registration Number, the FEI has 10 digits....
The FDA provides a public database for registered medical device establishments. Upon registration, each establishment receives an owner/operator number that could be accepted as an FDA registration number for shipment clearance purposes. However, the FDA can take 90 days to assign an official FDA ...
This document supersedes and replaces, “A Modular Approach to PMA Review,” dated January 29, 1998, and “Guidance for the Medical Device Industry on PMA Shell Development and Modular Review,” dated November 6, 1998. For questions regard...
您可以查阅FDA官方网站上的相关资料,例如《食品法典》(Food Code)、《药物法典》(Drug Code)、医疗器械分类数据库(Medical Device Classification Database)等,来了解产品的分类依据。 产品功能和用途:考虑产品的主要功能和用途是确定其分类的重要因素。例如,如果产品是一种食品补充剂,那么它可能属于食品类别;如果产品...
each IRB chairperson’s name, phone number, and electronic mail address; and the name, mailing address, phone number, facsimile number, and electronic mail address of the contact person providing the registration information; (3) The approximate number of active protocols involving FDA-regulated prod...