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US FDA exempts low-risk, some Class II devices from 510(K) requirements

Discussion in 'US Medical Device Regulations' started by nikolaos, Aug 11, 2015.

  1. nikolaos

    nikolaos Member

    Aug 11, 2015
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    Dear All,
    I have this information and want to share this with you:

    The US Food and Drug Administration has exempted about 120 additional device product codes from 510(k) pre-market notification requirements in a final guidance issued on July1.

    The identified devices are Class II, Class I or unclassified devices that the FDA now says “are sufficiently well understood and do not require 510(k) notification to assure their safety and effectiveness.”

    The agency said it planned to initiate a formal exemption via rulemaking or the order process for the devices but, in the meantime, it does not intend to enforce 510(k) compliance for these device categories.

    The FDA said it would identify more low-risk devices to exempt from premarket notification requirements as part of its 2012 user fee reauthorization commitments and this guidance is aimed at fulfilling that pledge. The agency issued a draft guidance to exempt low-risk devices in August 20142. The final version is similar to last year's proposal, but adds an additional 16 product codes to the list, and removes two products from the proposed exemption list. Among the added products are patient beds with canopy/restraints (product code: OYS), dental irrigating syringes (EIB) and spine curvature monitors (LZW).

    What's off the list
    Additionally, the FDA said it decided against its 2014 proposal to exempt electrical clinical thermometers (FLL) and preformed alterable cranioplasty plates (GWO).

    "Notably, the FLL product code currently covers thermometers with a range of technologies and intended uses, including those used to screen for potential pandemic contagious diseases," the FDA said.

    Some thermometer types may be candidates for 510(k) exemption, according to the FDA's device center, CDRH, but the devices first need to be further categorized into distinct product codes by technology or intended use. "CDRH is actively reviewing this issue and will further consider which of the sub-types may be appropriate to exempt from premarket notification requirements," the agency said.

    The cranioplasty plates, meanwhile, were unintentionally included in the draft guidance, the FDA said. They are permanent implants that require FDA evaluation of material properties and resorption rates.

    The agency is giving manufacturers who started selling devices in these two categories since the 2014 draft guidance 90 days to submit a 510(k) application if they did not do so initially.

    Overall, the FDA is exempting devices from 11 clinical categories:

    - anesthesiology (eg, nitrogen dioxide analyzers and cutaneous oxygen monitors);

    - cardiology (eg, lung sound monitors and oscillometers);

    - urology-gastroenterology (eg, colostomy rods and fiberoptic glass ureteral light catheters);

    - general and plastic surgery (eg, surgical drapes);

    - neurological (eg, vibration threshold measurement device);

    - obstetrical and gynecological (eg, proceptive fertility diagnostic);

    - ear, nose and throat (eg, electroglottograph);

    - dental (eg, endodontic stabilizing splint);

    - general hospital and personal use (eg, patient lubricant);

    - ophthalmic (eg, AC-powered euthyscope); and

    - physical medicine (eg, spine curvature monitor).

    This article has also been published in The Gray Sheet.


    1. Intent to Exempt Certain Unclassified, Class II and Class I Reserved Medical Devices from Premarket Notification Requirements, Guidance for Industry and Food and Drug Administration Staff, 1 July 2015, www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf

    2. US FDA exempts more than 100 devices from 510(k) requirements, Scrip Regulatory Affairs, 11 August 2014

  2. Zara Joyce

    Zara Joyce Member

    May 5, 2017
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    Thanks for the information. It will help me a lot.