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  2. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    21 CFR 820.30 on the FDA website ; MDD 93/42/EEC ; References This page was last edited on 26 October 2020, at 17:49 (UTC). Text is available under the Creative ...

  3. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

  4. Design history file - Wikipedia

    en.wikipedia.org/wiki/Design_history_file

    A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.

  5. Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Code_of_Federal_Regulations

    A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...

  6. Independent reviewer - Wikipedia

    en.wikipedia.org/wiki/Independent_reviewer

    The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...

  7. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) Various keynote speeches by FDA insiders early in the 21st century (in addition to high-profile audit findings focusing on computer system compliance) resulted in many companies scrambling to mount a defense against rule enforcement that they were procedurally ...

  8. Template:Cfr - Wikipedia

    en.wikipedia.org/wiki/Template:Cfr

    This template should always be substituted (i.e., use {}). This template is used by one or more bots . If you intend to change this template in any significant way, move it or nominate it for deletion, please inform the bot operators.

  9. Talk:21 CFR 820 - Wikipedia

    en.wikipedia.org/wiki/Talk:21_CFR_820

    Pharmacology Wikipedia:WikiProject Pharmacology Template:WikiProject Pharmacology pharmacology Start a discussion about improving the 21 CFR 820 page Talk pages are where people discuss how to make content on Wikipedia the best that it can be.

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