Received: from nobody by stodi.digitalkingdom.org with local (Exim 4.92) (envelope-from ) id 1jWSxS-0008IK-6Q for lojban-newreal@lojban.org; Wed, 06 May 2020 15:56:06 -0700 Received: from [192.254.68.238] (port=13233 helo=yellow.ebylearningnetwork.com) by stodi.digitalkingdom.org with esmtp (Exim 4.92) (envelope-from ) id 1jWSxQ-0008HW-6B for lojban@lojban.org; Wed, 06 May 2020 15:56:05 -0700 DKIM-Signature: v=1; a=rsa-sha1; c=relaxed/relaxed; s=holxjd; d=ebylearningnetwork.com; h=To:Reply-To:Message-ID:MIME-Version:Subject:From:Content-Type:Date; i=infrared.testing@ebylearningnetwork.com; bh=3xqHqms9N6sAzdKM8R9M5SBxZMw=; b=YiJijWYE2ypqoWta9ULQakBPauL6T4N9DEYbjm98vjPGUPrPppVGW1mz+mcF9o3isSIvl8rl9AXa tLTFN4b+CfjIyVMs8hq9BCR4J4thpPpGxn+lVh6TdqfnIPmbhbr+y2SUVZphQmz1EHvUNCfWZckT WMdC+DV+MP0ZMgeaSQ4= To: lojban@lojban.org Reply-To: infrared.testing@ebylearningnetwork.com Message-ID: <46954460387537087222065.8934064226.870412722410853.guidance@yellow.ebylearningnetwork.com> MIME-Version: 1.0 Subject: Easy-to-use infrared thermometers. Temporarily back. From: Infrared Testing Content-Type: multipart/alternative; boundary="-----4hQhdig65v2gksIRqIZS" Date: Wed, 6 May 2020 18:56:04 -0400 X-Spam-Score: -1.3 (-) X-Spam_score: -1.3 X-Spam_score_int: -12 X-Spam_bar: - -------4hQhdig65v2gksIRqIZS Content-type: text/plain; charset="UTF-8" Content-transfer-encoding: 8bit This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act. Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 (https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf) ," this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices. http://test.ebylearningnetwork.com/information/ http://test.ebylearningnetwork.com/information/ >http://www.ebylearningnetwork.com/information/r7Er9ZSv/ >MoreinformationabouttheEnforcementPolicyforClinicalElectronicThermometers.FinalGuidanceDocument(https://www.fda.gov/media/136698/download) >* > > >**CONTENTCURRENTASOF: >------------------------------------------------------------ > >04/04/2020 * ** REGULATED PRODUCT(S) ------------------------------------------------------------ * Medical Devices ** TOPIC(S) ------------------------------------------------------------ * Premarket * Postmarket ** HEALTH TOPIC(S) ------------------------------------------------------------ * Coronavirus -------4hQhdig65v2gksIRqIZS Content-Type: text/html; charset="UTF-8" Content-transfer-encoding: 8bit Untitled

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act.

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

block-quote
More information about the Enforcement Policy for Clinical Electronic Thermometers. Final Guidance Document

  • Content current as of:

  • Regulated Product(s)

    • Medical Devices

    Topic(s)

    • Premarket
    • Postmarket

    Health Topic(s)

    • Coronavirus
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