{"id":486257,"date":"2024-01-15T01:43:19","date_gmt":"2024-01-15T06:43:19","guid":{"rendered":"https:\/\/platohealth.ai\/fda-guidance-on-notifying-on-discontinuance-or-interruption-conditions-fda\/"},"modified":"2024-01-15T04:34:17","modified_gmt":"2024-01-15T09:34:17","slug":"fda-guidance-on-notifying-on-discontinuance-or-interruption-conditions-fda","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-guidance-on-notifying-on-discontinuance-or-interruption-conditions-fda\/","title":{"rendered":"FDA Guidance on Notifying on Discontinuance or Interruption: Conditions | FDA","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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This article highlights the aspects related to the approach to be applied when determining whether a notification is required.<\/span><\/div>\n<\/p><\/div>\n

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

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The<\/span> Food and Drug Administration<\/b><\/a> (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the procedures related to notifying the authority of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act. <\/span>
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<\/span>The document provides an overview of the applicable regulatory requirements, as well as additional clarifications to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto. <\/span>
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<\/span>At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. <\/span>
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<\/span>Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance. <\/span><\/p>\n

The authority issued the present comprehensive guidance to managing disruptions in the medical device supply chain. <\/span>
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<\/span>Recommendations provided in this guidance are crucial for ensuring a continuous supply of medical devices, which is particularly significant during public health emergencies (PHEs).<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Definitions<\/strong><\/span><\/h2>\n

The document provides definitions of the most important terms and concepts used in the context of the guidance, including:<\/span><\/p>\n