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  1. www.fda.gov › medical-devices › pingguzhongguozhizaodesuliao评估中国制造的塑料注射器的潜在器械故障 | FDA簡

    美国食品药品监督管理局 (FDA) 正宣布对江苏神力医用制品有限公司采取进一步的措施，对其不符合器械质量体系要求又发布了一条 进口预警 ，以防止该制造商生产的所有塑料注射器进入美国。 我们还对我们的建议进行了更新： 由于存在潜在质量和性能问题，在另行通知之前，本机构建议美国塑料注射器的供应商、消费者、医疗服务提供者和医疗机构立即停止使用江苏神力医用制品有限公司生产的所有型号塑料注射器（包括...

  2. www.fda.gov › cosmetics › registration-listing-cosmeticRegistration & Listing of Cosmetic Product Facilities ...

    2023年9月15日 · Facility Registration. Manufacturers and processors must register their facilities with FDA and renew their registration every two years.

  3. www.fda.gov › medical-devices › device-registration-andSearch Registration and Listing | FDA

    Search the Registration & Listing database. Establishment Registration and Medical Device Listing Files for Download. Releasable establishment registration and listing information under the ...

  4. www.fda.gov › medical-devices › quality-system-qs-regulationQuality Management System Regulation: Final Rule Amending ...

    2024年1月31日 · The FDA amended the title of the Quality System Regulation, and established requirements that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to...

  5. www.fda.gov › combination-products › guidance-regulatoryCombination Products Guidance Documents | FDA

    2022年1月28日 · The Office of Combination Products (OCP) develops cross-cutting FDA guidance for product classification, jurisdiction and combination products. Product-specific guidance provided by each of the ...

  6. www.fda.gov › media › 107708Regulatory Considerations for Microneedling Products - ...

    This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21...

  7. www.fda.gov › media › 94786美國食品藥物管理局（英文縮寫“FDA”）提供這些譯文 ...

    如何監控進口商品？ 為監控進口商品，FDA 與 美國海關及邊境保衛局（CBP）密切合作。 進口的化妝品在進入美國 時必須接受 CBP 的檢查。