FDA issues new draft guidance on medical device product codesJonathan S. KahanLina R. Kontos
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 ...
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...
• 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...
(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...
FDA issues new draft guidance on medical device product codes The article presents information on the Food and Drug Administration's new guidance for pharmaceutical and medical device companies. The guidance is on two topics, distributing documents on the unauthorized uses of drugs and medical devi....
FDA Product Codes
Unlike all prescription and over-the-counter drugs, which have individual identifying numbers known as National Drug Codes, "many medical devices currently do not have a unique identifier that clearly distinguishes one product from another," the agency noted. "The UDI system will provide a consisten...
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...
The number of product codes on the FDA’smedical device shortages listremains at four, down fromfive in Februarybutunchanged since the more recent update in July. The device shortage list does not include IV bags,domestic production of which was disrupted by Hurricanes Helene and Milton. Howe...