{"id":17324,"date":"2021-02-22T14:14:44","date_gmt":"2021-02-22T13:14:44","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17324"},"modified":"2023-12-12T16:07:55","modified_gmt":"2023-12-12T15:07:55","slug":"usa-fda-510-k-permanent-exemption-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/02\/22\/usa-fda-510-k-permanent-exemption-medical-devices\/","title":{"rendered":"USA: exemptions from Premarket Notification 510(k) requirements for some Medical Devices"},"content":{"rendered":"\n

In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA<\/strong> published a notice in the Federal Register which highlights the relaxation<\/strong> of numerous regulatory<\/strong>, including a waiver of Premarket Notification 510(k) requirements, <\/strong>that is,<\/strong> the Premarket notification requirements under section <\/strong>510(k).<\/p>\n\n\n\n

\"USA
Exemptions from Premarket Notification 510(k) requirements for some Medical Devices<\/figcaption><\/figure>\n\n\n\n

For seven Class I Medical Devices <\/strong>it has been provided permanent exemption from the<\/strong> Premarket Notification 510(k) requirements, <\/strong>as products have not shown adverse events <\/strong>and they have been assessed as sufficiently safe and effective. <\/p>\n\n\n\n

Which Class I devices\nare now exempt from the Premarket Notification 510(k)<\/strong> requirements?<\/strong><\/h2>\n\n\n\n
Medical Device description <\/strong> <\/td>Class of the Medical Device <\/strong> <\/td>Product Code<\/strong> <\/td>Section 21 CFR<\/strong> <\/td><\/tr>
Powder-Free Polychloroprene Patient Examination Glove<\/td>I <\/td>\n OPC\n <\/td>880.6250 <\/td><\/tr>
Patient Examination Glove, Specialty<\/td>I <\/td>\n LZC\n <\/td>880.6250 <\/td><\/tr>
Radiation Attenuating Medical Glove<\/td>I <\/td>\n OPH\n <\/td>880.6250 <\/td><\/tr>
Powder-Free Non-Natural Rubber Latex Surgeon\u201ds Gloves<\/td>I <\/td>\n OPA\n <\/td>878.4460 <\/td><\/tr>
Powder-Free Guayle Rubber Examination Glove<\/td>I <\/td>\n OIG\n <\/td>880.6250 <\/td><\/tr>
Latex Patient Examination Glove<\/td>I<\/td>\n LYY\n <\/td>880.6250 <\/td><\/tr>
Vinyl Patient Examination Glove <\/td>I<\/td>\n LYZ\n <\/td>880.6250 <\/td><\/tr><\/tbody><\/table>\n\n\n\n

Further proposed exemptions for Class II devices<\/strong><\/h2>\n\n\n\n

By virtue of\nlack of adverse event reports, FDA also proposed exemptions for 83 Class II\nMedical Devices <\/strong>and one unclassified\ndevice. <\/strong><\/p>\n\n\n\n

Medical\nDevices that are the subject of these proposals include a wide range of\nproducts and systems, such as N95 respirators, MD detergents and software for\nelectrocardiography.<\/p>\n\n\n\n

The complete list of these devices has been published in the table n\u00b0 6 of the FDA notice on the Federal Register<\/a>.<\/p>\n\n\n\n

Thanks to these exemptions, FDA could ensure increased availability of Medical Devices and technologies useful to counter the COVID-19 pandemic. <\/p>\n\n\n\n

Would you like more\ninformation about 510 (k)?<\/strong><\/strong><\/h2>\n\n\n\n

Rely on Thema experts for a valuable<\/strong> strategic-regulatory consultancy<\/a>. <\/strong>
Contact us<\/a><\/strong> and find out what we can do for you.<\/p>\n\n\n\n

Source:<\/em><\/p>\n\n\n\n

 FDA notice on the Federal Register <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1568],"class_list":["post-17324","post","type-post","status-publish","format-standard","hentry","category-news-en","tag-usa-topic"],"acf":[],"yoast_head":"\nUSA: FDA 510(k) permanent exemption for certain Medical Devices<\/title>\n<meta name=\"description\" content=\"The U.S. FDA has introduced a 510(k) permanent exemption for certain Class I Medical Devices to combat the COVID-19 pandemic.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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