{"id":4338,"date":"2015-08-18T03:01:47","date_gmt":"2015-08-18T03:01:47","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4338"},"modified":"2015-08-18T03:01:47","modified_gmt":"2015-08-18T03:01:47","slug":"fda-updates-guidance-on-device-classes-exemptions-from-premarket-notifications-requirements","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/08\/18\/fda-updates-guidance-on-device-classes-exemptions-from-premarket-notifications-requirements\/","title":{"rendered":"FDA Updates Guidance on Device Classes Exemptions from Premarket Notifications Requirements"},"content":{"rendered":"

\"\"<\/a>This post covers 8 product codes added & updates made to the guidance on Device Classes Exemptions from Premarket Notifications Requirements<\/span><\/p>\n

On Aug 14, 2015 FDA updated the Final Guidance Document titled \u201cIntent to <\/strong>Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements\u201d.\u00a0 It was originally issued as a Final Guidance on July 1, 2015.\u00a0 The main change for this current revision was to add 8 product codes that were overlooked due to an administrative error where the FDA missed some comments from a public consultation.\u00a0 Additionally, they added a couple important clarifications to the Guidance.<\/span><\/p>\n

This Guidance describes the FDA\u2019s intent to exempt the product codes mentioned in this Guidance of the unclassified medical devices, and Class II & I medical devices that are subject to section 510(l) of the FD&C Act, from premarket notification requirements.\u00a0 The FDA believes devices identified in this Guidance document (Section IV) are well understood & don\u2019t require premarket notification (510(k)) to assure their safety & effectiveness. \u00a0So, the FDA intends to propose exempting these devices from premarket notification requirements of section 510(l) & (m) of the FD&C Act, subject to limitations on exemption criteria in a slew of 21 CFR sections in the 868.9 to 890.9 range (refer to Guidance for details). \u00a0When FDA publishes such a proposal it will be published in the Federal Register but until the publication of a final rule or order exempting these devices from 510(k), the FDA doesn\u2019t intend to enforce compliance with 510(k) requirements for these identified devices.\u00a0 Therefore, the FDA doesn\u2019t expect manufacturers to submit 510(k)s for these devices during this time period.<\/span><\/p>\n

The 2 clarifications are: 1) It is not FDA\u2019s intent to exempt any combination products that fall under the list of product codes that are subjected to this Guidance Document.\u00a0 2) The product codes mentioned in the Guidance that contain an antimicrobial agent are not within the scope of this Guidance.<\/span><\/p>\n

The product codes added to the latest version of the Guidance include:<\/span><\/p>\n