{"id":554,"date":"2016-06-13T19:28:03","date_gmt":"2016-06-13T19:28:03","guid":{"rendered":"https:\/\/awrightpath.net\/?p=554"},"modified":"2019-06-05T19:29:41","modified_gmt":"2019-06-05T19:29:41","slug":"fda-implements-administrative-changes-for-modular-premarket-approval-applications-pmas-effective-june-13-2016","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/fda-implements-administrative-changes-for-modular-premarket-approval-applications-pmas-effective-june-13-2016\/","title":{"rendered":"FDA Implements Administrative Changes for Modular Premarket Approval Applications (PMAs); Effective June 13, 2016"},"content":{"rendered":"\n<p>Dear Modular PMA Holder:<br>We are writing to inform you that effective June 13, 2016, FDA?s Center for Devices and Radiological Heath (CDRH) has implemented several process changes involving Modular PMAs.&nbsp; These changes are the latest in a series of process changes regarding premarket submissions (previous changes involved premarket notifications (510(k)s), investigational device exemptions (IDEs), humanitarian device exemptions (HDEs), and PMAs).&nbsp; The process changes primarily address how incoming submissions are identified and numbered, and how CDRH will communicate decisions on incoming submissions.<br>This table identifies aspects of the Modular PMA and the associated process change:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td><strong>Modular PMA aspect<\/strong><\/td><td><strong>Before June 13, 2016<\/strong><\/td><td><strong>Starting June 13, 2016<\/strong><\/td><\/tr><tr><td>PMA Shell:&nbsp; module identification<\/td><td>applicant specifies:&nbsp;<br>(1) module number (e.g., M001) and&nbsp;<br>(2)&nbsp;descriptive title (e.g., biocompatibility)<\/td><td>applicant specifies:&nbsp;<br>(1) descriptive title (e.g., biocompatibility)<\/td><\/tr><tr><td>PMA Module:&nbsp; numbering<\/td><td>pre-assigned by sponsor with submission of PMA Shell<\/td><td>assigned sequentially by FDA (i.e., M001, then M002, etc.) as Modules are submitted<\/td><\/tr><tr><td>Individual PMA Module:&nbsp;&nbsp;<br>changes to accepted module<\/td><td><strong>supplement<\/strong>&nbsp;to Module<\/td><td><strong>amendment<\/strong>&nbsp;to Module<\/td><\/tr><tr><td>Entire Modular PMA submission:&nbsp; request to withdraw<\/td><td><strong>amendment<\/strong>&nbsp;to Modular PMA Shell (e.g., A001)<\/td><td><strong>withdrawal document<\/strong>&nbsp;to Modular PMA Shell (e.g., WD001)<\/td><\/tr><tr><td>Individual PMA module:&nbsp; request to withdraw<\/td><td><strong>amendment<\/strong>&nbsp;to individual PMA Module<\/td><td><strong>withdrawal<\/strong>&nbsp;<strong>document<\/strong>&nbsp;to individual PMA Module<\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>&nbsp;<br>This table identifies the CDRH decisions that will now be communicated via an email only, instead of an email with a letter.&nbsp; There is no change in processing of PMA Modules on Manufacturing:<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td><strong>Purpose of communication<\/strong><\/td><td><strong>CDRH Action before June 13, 2016<\/strong><\/td><td><strong>CDRH Action starting June 13, 2016<\/strong><\/td><\/tr><tr><td>PMA Shell:&nbsp; acceptance<\/td><td>send email with letter noting acceptance of shell and including accepted shell as attachment.<\/td><td>send email stating that CDRH has reviewed your proposed modular PMA shell and agrees with your proposed shell. &nbsp;Email will include a copy of the accepted shell.<\/td><\/tr><tr><td>PMA Module:&nbsp; acceptance<\/td><td>send email with letter noting acceptance of module.<\/td><td>send email stating that CDRH has reviewed your proposed PMA module, and that module is accepted and is now considered closed.<\/td><\/tr><tr><td>Entire PMA Shell\/Module:&nbsp; withdrawal<\/td><td>send email with letter noting acceptance of withdraw.<\/td><td>send email stating that CDRH has reviewed your request to withdraw a module or a modular PMA, and the submission is now considered withdrawn.<\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>&nbsp;<br><strong>Frequently Asked Questions:<\/strong><\/p>\n\n\n\n<p><strong>What will happen to module numbering if I have submitted a Modular PMA prior to June 13, 2016?<\/strong><br>Existing modules will keep their module numbering.&nbsp; Any new modules submitted on or after June 13, 2016, will be assigned a number sequentially, with the next number after the prior module of the highest number.&nbsp; For example, if you previously submitted M002 and M004, the next module will be assigned M005.&nbsp; As a result, the numbering for new modules will likely differ from what is listed in a PMA Shell accepted prior to June 13, 2016.<br>&nbsp;<br><strong>Will these changes affect the review clock of submissions currently under review?<\/strong><br>No.&nbsp; These changes will not impact the review clock for submissions currently under review.<\/p>\n\n\n\n<p><strong>Do I need to submit an amendment to my Modular PMA Shell to change the numbering of the modules?<\/strong><br>No.&nbsp; Each new module will be numbered sequentially as it is received.&nbsp; When submitting new modules please identify the module accordingly to its descriptive title, e.g.,? Preclinical Testing,? ?<strong>Biocompatibility Testing,? etc.<\/strong><\/p>\n\n\n\n<p><strong>If you have any questions about these changes, please contact the&nbsp;<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/ContactUs--DivisionofIndustryandConsumerEducation\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Division of Industry and Consumer Education<\/a>&nbsp;(DICE) at&nbsp;<a href=\"mailto:DICE@fda.hhs.gov\" target=\"_blank\" rel=\"noreferrer noopener\">DICE@fda.hhs.gov<\/a>&nbsp;or by phone at&nbsp;<a href=\"tel:18006382041\" target=\"_blank\" rel=\"noreferrer noopener\">(800) 638-2041<\/a>&nbsp;or&nbsp;<a href=\"tel:13017967100\" target=\"_blank\" rel=\"noreferrer noopener\">(301) 796-7100<\/a>.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dear Modular PMA Holder:We are writing to inform you that effective June 13, 2016, FDA?s Center for Devices and Radiological Heath (CDRH) has implemented several process changes involving Modular PMAs.&nbsp; These changes are the latest in a series of process changes regarding premarket submissions (previous changes involved premarket notifications (510(k)s), investigational device exemptions (IDEs), humanitarian [&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 Implements Administrative Changes for Modular Premarket Approval Applications (PMAs); Effective June 13, 2016 - A Wright Path | Right Path. 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