{"id":527,"date":"2016-09-09T18:58:42","date_gmt":"2016-09-09T18:58:42","guid":{"rendered":"https:\/\/awrightpath.net\/?p=527"},"modified":"2019-06-05T19:02:09","modified_gmt":"2019-06-05T19:02:09","slug":"fda-issues-draft-guidance-for-510k-third-party-tp-review-program","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-for-510k-third-party-tp-review-program\/","title":{"rendered":"FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program"},"content":{"rendered":"\n<p>Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled ?<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM339697.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">510(k) Third Party Review Program<\/a>.? The purpose of this draft guidance is to explain the FDA?s 510(k) Third Party (TP) Premarket Review Program, formerly known as the Accredited Persons (AP) Program. Under the FDA?s TP Premarket Review Program, authorized by federal law,&nbsp;<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfThirdParty\/Accredit.cfm\" target=\"_blank\" rel=\"noreferrer noopener\">recognized organizations<\/a>&nbsp;are allowed to review&nbsp;<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfThirdParty\/current.cfm\" target=\"_blank\" rel=\"noreferrer noopener\">certain eligible low-to-moderate risk 510(k) devices<\/a>, which may yield faster 510(k) decisions.<\/p>\n\n\n\n<p>Within this draft guidance, the FDA proposes criteria of the TP Premarket Review Program in the following areas:<\/p>\n\n\n\n<ul><li>TP Review Organizations review of 510(k) premarket submissions;<\/li><li>Requirements and recommendations for recognition and rerecognition of TP Review Organizations;<\/li><li>Content and format of a TP Review Organization?s application for initial recognition and rerecognition; and<\/li><li>Suspension or withdrawal of recognition.<\/li><\/ul>\n\n\n\n<p>This draft guidance replaces the 2013 draft guidance entitled ?Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I ? Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers.? Additionally, in an effort to harmonize the terms used by the&nbsp;<a href=\"http:\/\/www.imdrf.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">International Medical Device Regulators Forum?s (IMDRF)<\/a>regulatory audit program called&nbsp;<a href=\"http:\/\/www.fda.gov\/medicaldevices\/internationalprograms\/mdsappilot\/default.htm?\" target=\"_blank\" rel=\"noreferrer noopener\">Medical Device Single Audit Program (MDSAP)<\/a>, this draft guidance uses terms such as ?recognition and rerecognition? instead of ?accreditation and reaccreditation.?<\/p>\n\n\n\n<p>We welcome your comments and suggestions regarding this draft guidance.&nbsp; The comment period will be open for 120 days in the&nbsp;<a href=\"https:\/\/www.federalregister.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">Federal Register<\/a>&nbsp;under docket number FDA-2016-D-2565 starting&nbsp;September 12, 2016.<\/p>\n\n\n\n<p>If you have any questions, please contact the Center for Devices and Radiological Health (CDRH) Third Party Review Program at&nbsp;<a href=\"mailto:3P510K@fda.hhs.gov\" target=\"_blank\" rel=\"noreferrer noopener\">3P510K@fda.hhs.gov<\/a>.<\/p>\n\n\n\n<p>Food and Drug Administration<br>Center for Devices and Radiological Health<br><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled ?510(k) Third Party Review Program.? The purpose of this draft guidance is to explain the FDA?s 510(k) Third Party (TP) Premarket Review Program, formerly known as the Accredited Persons (AP) Program. Under the FDA?s TP Premarket Review Program, authorized by federal [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":335,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program - A Wright Path | Right Path. 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