{"id":2261,"date":"2011-11-14T06:18:23","date_gmt":"2011-11-14T06:18:23","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2261"},"modified":"2011-11-14T06:18:23","modified_gmt":"2011-11-14T06:18:23","slug":"fda-extends-comment-period-on-510k-guidance","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2011\/11\/14\/fda-extends-comment-period-on-510k-guidance\/","title":{"rendered":"FDA Extends Comment Period on 510(k) Guidance"},"content":{"rendered":"<p><span style=\"font-size: small;\">On November 8, 2011 FDA issued a <a title=\"FDA Federal Register Notice for extension of the comment period\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2011-11-08\/html\/2011-28875.htm\" target=\"_blank\" rel=\"noopener noreferrer\">notice in the Federal Register<\/a> extending the public comment period for the <a title=\"FDA Draft Guidance &quot;510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device&quot;\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm265274.htm\" target=\"_blank\" rel=\"noopener noreferrer\">draft Guidance Document &#8220;510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device&#8221;<\/a> from October 25, 2011 to November 28, 2011.<\/span><\/p>\n<p><span style=\"font-size: small;\">In the <a title=\"FDA Federal Register Notice for extension of the comment period\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2011-11-08\/html\/2011-28875.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Federal Register Notice<\/a> the FDA said &#8220;The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.&#8221;<\/span><\/p>\n<p>Per a <a href=\"http:\/\/www.massdevice.com\/news\/fda-extends-comment-period-510k-guidance-doc\" target=\"_blank\" rel=\"noopener noreferrer\">Mass Device web article of November 8, 2011<\/a> &#8220;The draft guidance is intended to update a 1977 guidance document, &#8216;Deciding When to Submit a 510(k) for a Change to an Existing 510(k).&#8217; It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that&#8217;s already won 510(k) clearance.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document &#8220;510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device&#8221; from October<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[45,460,461,462,463,85,464,465,9,334,10,191,466,330,312,372,175,149,268,467],"class_list":["post-2261","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-510k","tag-510k-clearance","tag-510k-draft-guidance-document","tag-510k-submission","tag-changes-to-an-existing-device","tag-draft-fda-guidance","tag-existing-510k","tag-existing-device","tag-fda","tag-fda-draft-guidance","tag-fda-guidance","tag-federal-register","tag-food-drug-administration","tag-medical-device","tag-medical-device-regulation","tag-medical-device-regulations","tag-medical-device-regulatory","tag-medical-devices","tag-placing-on-the-market-of-medical-devices","tag-product-changes-510k"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2261","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=2261"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2261\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2261"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2261"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2261"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}