General Investor Information EBR Systems, page-295

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Lumpymash

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17/08/24

13:36

Post #: 75250998
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Originally posted by Innameonly: ↑

This is straight from ChatGPT in reply to your question in your post.

Under the modular Premarket Approval (PMA) application model, modules are typically scrutinized and reviewed as they are submitted. This approach allows for an ongoing dialogue between the applicant and the FDA during the submission process, enabling the FDA to provide feedback on each module before the entire application is complete.

Here's how it generally works:

Submission of Modules: The applicant submits different sections (modules) of the PMA application over time, rather than submitting a full application all at once.

Review Process: The FDA reviews each module as it is received. This can include modules related to preclinical data, clinical data, manufacturing processes, and other necessary information.

Feedback: The FDA provides feedback on the submitted modules, which can be used by the applicant to refine subsequent modules. This iterative process helps to address potential issues early, reducing the risk of significant delays later in the approval process.

Final Decision: Once all modules are submitted and reviewed, the FDA makes a final decision regarding the approval of the medical device.

This modular approach is particularly useful for complex medical devices, as it allows for a more structured and manageable review process for both the applicant and the FDA.

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Thank you.
And what a quick reply !!
Lumpymash

EBR Price at posting: $1.17 Sentiment: Buy Disclosure: Held
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General Investor Information EBR Systems, page-295

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General Investor Information EBR Systems, page-295

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