{"id":79640,"date":"2024-01-14T06:33:34","date_gmt":"2024-01-14T06:33:34","guid":{"rendered":"https:\/\/shoppingdealer.com\/?p=79640"},"modified":"2024-01-14T06:33:34","modified_gmt":"2024-01-14T06:33:34","slug":"medical-devices-fdas-510k-operations-could-be-improved-pemd-88-14","status":"publish","type":"post","link":"https:\/\/shoppingdealer.com\/?p=79640","title":{"rendered":"Medical Devices: FDA&#8217;s 510(k) Operations Could Be Improved: Pemd-88-14"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/m.media-amazon.com\/images\/I\/51xt5P60XeL.jpg\" class=\"wp_automatic_gallery\" \/><img decoding=\"async\" src=\"https:\/\/m.media-amazon.com\/images\/I\/41c4en-1B6L.jpg\" class=\"wp_automatic_gallery\" \/><br \/>\nPrice: <span style=\"color:#b12704\">[price_with_discount]<\/span><br \/><i><small>(as of [price_update_date] &#8211; <span class=\"wp_automatic_amazon_disclaimer\" title=\"Product prices and availability are accurate as of the date\/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.\">Details<\/span>)<\/small><\/i><\/p>\n<p><a href=\"https:\/\/amazon.com\/dp\/1289010552?tag=e038-20\"><img data-recalc-dims=\"1\" decoding=\"async\" src=\"https:\/\/i0.wp.com\/i.imgur.com\/ISRHEWs.png?w=720&#038;ssl=1\"><\/a><br \/>\n[ad_1]<br \/>\n  In response to a congressional request, GAO examined the Food and Drug Administration&#8217;s (FDA): (1) implementation of the premarket notification provision of the Medical Device Amendments of 1976; and (2) day-to-day operations in making its determinations of substantial equivalence. GAO found that: (1) although FDA guidance for determining substantial equivalence was generally adequate and consistent with the less restrictive reading of the act, its description of performance assessment contained some ambiguities; (2) differences among the reviewing divisions within the Office of Device Evaluation (ODE) concerning manufacturer information suggested a lack of clear office-wide policy and coordination; (3) documentation of premarket notifications was inadequate to evaluate ODE compliance with formal review policy; (4) because of implementation problems, certain classes of medical devices did not meet requirements appropriate to their classification and FDA relied on premarket notifications to control market access to them; and (5) FDA reliance on products marketed prior to 1976 to determine substantial equivalence could cause problems.    <\/p>\n<p> Publisher                                    \u200f                                        :                                    \u200e                                 Bibliogov (June 26, 2013) <br \/> Language                                    \u200f                                        :                                    \u200e                                 English <br \/> Paperback                                    \u200f                                        :                                    \u200e                                 116 pages <br \/> ISBN-10                                    \u200f                                        :                                    \u200e                                 1289010552 <br \/> ISBN-13                                    \u200f                                        :                                    \u200e                                 978-1289010553 <br \/> Item Weight                                    \u200f                                        :                                    \u200e                                 7.8 ounces <br \/> Dimensions                                    \u200f                                        :                                    \u200e                                 7.44 x 0.24 x 9.69 inches <\/p>\n<p>[ad_2]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Price: [price_with_discount](as of [price_update_date] &#8211; Details) [ad_1] In response to a congressional request, GAO examined the Food and Drug Administration&#8217;s (FDA): (1) implementation of the premarket notification provision of the Medical Device Amendments of 1976; and (2) day-to-day operations in making its determinations of substantial equivalence. GAO found that: (1) although FDA guidance for determining substantial equivalence was generally adequate [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":79641,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[46],"tags":[],"class_list":["post-79640","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-and-surgical"],"aioseo_notices":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/shoppingdealer.com\/wp-content\/uploads\/2024\/01\/51xt5P60XeL.jpg?fit=384%2C500&ssl=1","jetpack_sharing_enabled":true,"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/posts\/79640","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=79640"}],"version-history":[{"count":0,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/posts\/79640\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=\/wp\/v2\/media\/79641"}],"wp:attachment":[{"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=79640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=79640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shoppingdealer.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=79640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}