Food Export Certificates | FDA
网页2022年9月15日 — The “Certificate of Exportability” is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States...
Forms | FDA - U.S. Food and Drug Administration
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Online Applications for Export Certificates for Food | FDA
网页2022年12月12日 — Industry may request most types of FDA-issued export certificates for food products through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS).
网页Form 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.
Form FDA 3674 - Certifications to Accompany …
网页This guidance describes the Food and Drug Administration’s (FDA, we, or Agency) current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and...
网页There are two variations to the standard Form FDA 3613 described below: For human cells, tissues, and cellular and tissue-based product (HCT/P) procured prior to May 25, 2005, the responsible official certifies compliance with applicable requirements of 21 CFR Part 1270.
Certifying Pharmaceutical Exports An Introduction To FDA's Certificate …
网页2021年2月1日 — FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requesting country. In Part 1 of a two-part series, we discuss the requirements for exporting U.S ...
FDA Industry Systems
网页The Act requires that FDA develop two systems: one to support the registration of facilities that manufacture, process, pack, or hold food products intended for consumption in the United States...
网页NOTE: At this time the Certificate of a Pharmaceutical Product is the only certificate type that can be requested online. For the Simple Notification, please fill out and send the appropriate application form to the following address: U.S. Food and Drug Administration . Center for Drug Evaluation and Research
网页Certification Form (Form FDA 3674): www.fda.gov/opacom/morechoices/ fdaforms/FDA-3674.pdf. Compliance. 510(k) submissions must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate National Clinical Trial control numbers.