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QSR 820 法规的修改历史

阅读: 2016年05月14日

QSR 820 法规的修改历史

 

  QSR 820 法规从1996年发布以来,历史上进行了6次小型的技术修改。如下

  Technical Amendment Federal Register Citation

  65 FR 17136

  (31-Mar-2000)

  Change removed paragraphs (e) and (f) from 820.1 Scope. PART 820—QUALITY SYSTEM REGULATION

  7. The authority citation for 21 CFR part 820 continues to read as follows:

  Authority: 351, 352, 360, 360c, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.

  8. Amend § 820.1 by removing paragraphs (e) and (f).

  --------------------------------------------------------------------------------

  65 FR 66636

  (07-Nov-2000)

  Change restored paragraph (e) to 820.1 Scope.

  PART 820—QUALITY SYSTEM REGULATION

  5. The authority citation for 21 CFR part 820 continues to read as follows:

  Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.

  6. Section 820.1 is amended by adding paragraph (e) to read as follows:

  § 820.1 Scope.

  * * * * *

  (e) Exemptions or variances. (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the FDA’s administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ–220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1–800–638–2041 or 1–301–443–6597, FAX 301–443–8818.

  (2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.

  --------------------------------------------------------------------------------

  69 FR 11313

  (10-Mar-2004)

  Change removed reference to 21 CFR 804, which was deleted from the CFR.

  PART 820—QUALITY SYSTEM REGULATION

  14. The authority citation for 21 CFR part 820 continues to read as follows:

  Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l 371, 374, 381, 383.

  15. Section 820.198(d) is revised to read as follows

  § 820.198 Complaint files.

  * * * * *

  (d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 820.198(e), records of investigation under this paragraph shall include a determination of:

  (1) Whether the device failed to meet specifications;

  (2) Whether the device was being used for treatment or diagnosis; and

  (3) The relationship, if any, of the device to the reported incident or adverse event.

  * * * * *

  16. Section 820.200(c) is revised to read as follows:

  § 820.200 Servicing.

  * * * * *

  c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.

  --------------------------------------------------------------------------------

  69 FR 29829

  (25-May-2004)

  Changed to specifically note applicability of 21

  CFR 820 to tissue products, under newly released 21 CFR 1271.

  Also, the Quality System regulation contains a typographic error: it has a date of 2005, but 2004 is the correct date.

  PART 820—QUALITY SYSTEM REGULATION

  6. The authority citation for 21 CFR part 820 is revised to read as follows:

  Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

  7. Section 820.1 is amended by adding two sentences to the end of paragraph (a)(1), and by revising paragraph (b) to read as follows:

  § 820.1 Scope.

  (a) Applicability. (1) * * *

  Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.

  * * * * *

  (b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.

  --------------------------------------------------------------------------------

  71 FR 16228

  (31-Mar-2006)

  Change removed reference to 21 CFR 804, which was deleted from the CFR. PART 820—QUALITY SYSTEM REGULATION

  3. The authority citation for 21 CFR part 820 continues to read as follows:

  Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383.

  4. Amend paragraph (a)(3) of § 820.198 by removing ‘‘or 804’’.

  --------------------------------------------------------------------------------

  72 FR 17397

  (09-Apr-2007)

  Change updated title, address, and phone numbers for DSMICA. PART 820—QUALITY SYSTEM REGULATION

  6. FDA is revising Sec.  820.1(e) and replacing “Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818” with “Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.”




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