Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, import- ers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also ...
upon request of an officer or em- ployee designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports. Subpart B—Procedures for Device Establishments 807.20 Who must reg...
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If a manu- product license application under sec- facturer who offers devices for import tion 351 of the Public Health Service into the United States refuses to per- Act) are subject to this part and are mit or allow the completion of a Food also subject to the donor-eligibility and Drug...
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803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的...
(1)ISO13485, “Medical devices—Quality management systems—Requirements for regulatory purposes,” ISO 13485,“医疗器械—质量管理体系—用于法规的要求”,第三版,2016 年 3 月;IBR 批准 §§ 820.1;820.3;820.10;820.15;820.35;820.45。 (2) [预留的] ...
it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put. Sec. 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device safely and ...
I (4–1–21 Edition) (iii) of this section, FDA will render a PART 801—LABELING decision within 45 days of the request for supervisory review. Subpart A—General Labeling Provisions (ii) A person requesting supervisory Sec. review under paragraph (b)(1)(i) may 801.1 Medical devices; ...
803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES ...