{"id":2758594,"date":"2023-06-30T14:18:58","date_gmt":"2023-06-30T18:18:58","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/fda-on-q-submission-program-submission-content-regdesk\/"},"modified":"2023-06-30T14:18:58","modified_gmt":"2023-06-30T18:18:58","slug":"fda-on-q-submission-program-submission-content-regdesk","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/fda-on-q-submission-program-submission-content-regdesk\/","title":{"rendered":"FDA on Q-Submission Program (submission content) – RegDesk"},"content":{"rendered":"
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The new article describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of Contents<\/span><\/h2>\n<\/div><\/div>\n

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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the requests for feedback and meetings for medical device submissions under the Q-Submission program. The said program allows medical device manufacturers to obtain feedback from the authority before submitting the main application for marking approval. The FDA expects this will be beneficial for the overall improvement of the submissions\u2019 quality, and also contribute to better allocation of review resources of the authority. <\/span><\/p>\n

It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the applicable regulations. <\/span><\/p>\n

In particular, the document describes in detail the process to be followed when submitting a request under the Q-Submission program. The authority provides additional clarifications regarding the content of submissions and applicable timeframes. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Submission Content: Cover Letter<\/span><\/h2>\n

First of all, the authority emphasizes the importance of ensuring the accuracy and completeness of requests. According to the guidance, a cover letter accompanying the Q-Submission request should contain the following elements:<\/span><\/p>\n