精品人妻少妇嫩草AV无码专区,99精品丰满人妻无码一区二区,寡妇高潮一级毛片免费看,欧美婬乱片A片AAA毛姪片
上海沃華產(chǎn)品技術(shù)服務(wù)有限公司,為您提供一站式的注冊(cè)服務(wù)!全國(guó)統(tǒng)一免費(fèi)服務(wù)熱線(xiàn):400-016-1080   021-51088618 Chinese/English
服務(wù)范圍
美國(guó)FDA質(zhì)量管理體系QSR820咨詢(xún)返回首頁(yè)

QSR 820 法規(guī)從1996年發(fā)布以來(lái),歷史上進(jìn)行了6次小型的技術(shù)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.”

企業(yè)介紹 | 法律聲明 | 網(wǎng)站地圖 | 認(rèn)證查詢(xún) | 資料下載 | 在線(xiàn)留言 | 聯(lián)系方式
上海沃華產(chǎn)品技術(shù)服務(wù)有限公司 Copyright 2025 www.smhvat.com, 版權(quán)所有 滬ICP備16037738號(hào)-1
電話(huà):021-51088618;400-016-1080 地址:上海市長(zhǎng)寧區(qū)天山路641號(hào)慧谷白貓科技園1號(hào)樓701室
友情鏈接: CE認(rèn)證 | BIM咨詢(xún) | 深圳注冊(cè)公司

滬公網(wǎng)安備 31010502002363號(hào)


国产乱码一区二区三区在线观看 | 高潮呻吟久久AV无码购买 | 免费看欧美A级黄色绿像 | 99up.cc成人网站 | 亚洲国精产品二二三三区 | 久久毛片www.17c.com | 国产精品人成A片一区二区 国产亚洲东北熟女高潮叫床 | 搡BBBB 搡BBB视频 | 成人网站在线观看免费 | 色欲av在线免费 | 欧美顶级黃色大片免费 | 天天日天天操天天干 | 欧美国产一区二区三区 | 国产精品久久毛片A片软件爽爽 | 国产亲子伦XXXXX对白 | 蜜桃久久一区二区蜜桃 | 精品人妻aV中文字幕乱 | 91精产国品一二三产区APP | 性一交一乱一色一免费无遮挡 | 北京熟妇搡BBBB搡BBBB | 国产乱码精品一品二品 | 国产色情性黄 免费观看 | 精品秘 一区二三区免费雷安 | 一区二区三区高清无码 | 给日本亚洲城市夫妻在家日穴 | 一级特黄妇女高潮视的特点 | 日本丰满无码一区久久 | 海量无码久久播放视频 | 少妇做爰毛片A片成人影院 特级大胆西西4444人体 | 一级婬片A片AAAA毛片A级 | 大陆三级片91制片厂 | 久久天天东北熟女毛茸茸 | 少妇高潮灌满白浆毛片免费看 | 成人av一区二区三区 | 午夜黄色视频在线观看 | 丰满少妇一 A片免费 | 国产做爰XXXⅩ性视频国 | 国产清纯大学生白嫩动态图 | 无码精品人妻一区二区三区影院 | 国产美女一级A片免费 | 日美嫩B嫩BBBBBB|