In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the second topic is Dossier for Clinical Laboratory Tests and Medical Devices. While the AMCP format can be used for medical devices, “it is recommended that medical devices that are most directly related to the use of a drug are most relevant and applicable for the AMCP Format.” Indeed, the AMCP Format encourages medical devices to create dossiers, keeping in mind that some areas of the format may not be applicable for medical devices. Further, the FDA’s Use of Real-world Evidence to Support Regulatory Decision-making for Medical Devices may be helpful in determining what types of real-world evidence and data to include.
Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with your medical device dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/
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