The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2021
The money will support the review of submissions and other activities. As in previous years, FDA will charge small businesses a reduced rate. If a business, including affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year, it may qualify for reduced small business fees. If a business, including affiliates, has gross sales or receipts of no more than $30 million, it may also qualify for a waiver of the fee for the first premarket application (i.e. PMA) or premarket report.
FDA issued a final guidance on its regulatory approach to multiple function device products, defined as products that have at least one device function and one non-device function (“other function”).
The final guidance document explains how the FDA intends to assess the impact of “other functions” on the safety and effectiveness of a device function that is subject to agency review. For purposes of this guidance, for any given product, the term “device function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product (e.g. diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease etc.).
In the guidance, FDA clarifies that its assessment will focus on the impact of any non-device functions on the safety and effectiveness of the device function, including analyses of whether the functions could be successfully partitioned and whether any potential impact would produce adverse or beneficial results. In addition, depending on the potential impact of other functions on the product’s device function, the regulated party may be required to take further action such as including additional content as part of a premarket submission, submitting a new 510(k), or modifying the device’s description or labeling.
FDA granted Caption Health (located in Brisbane, CA) 510(k) clearance for its artificial intelligence-based software that automatically selects the best clips from ultrasound exams for measuring cardiac ejection fraction — the amount of blood the heart’s left ventricle pumps out during each contraction.
FDA identifies this generic type of device as:
Radiological acquisition and/or optimization guidance system – A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
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