Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 166

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 166
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 PMA application. Pursuant to the
Food and Drug Administration Safety and Innovation Act, or FDASIA, manufacturers may request the de novoclassification pathway
by permitting manufacturers to request de novoclassification directly without first submitting a 510(k) pre-market notification
to the FDA and receiving a not-substantially-equivalent determination. De novoclassification requests are subject to the payment
of user fees, which for fiscal year 2025, includes a standard fee of $162,235.

Under FDASIA, FDA is required
to classify the device within 120 days following receipt of the de novorequest, although the process may take significantly longer.
If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are
necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. If FDA grants the de novorequest,
the device may be legally marketed in the United States. However, the FDA may reject the request if the FDA identifies a legally marketed
predicate device that would be appropriate for a 510(k) notification, determines that the device is not low-to-moderate risk, or determines
that general controls would be inadequate to control the risks and/or special controls cannot be developed. After a device receives de
novoclassification, any modification that could significantly affect its safety or efficacy, or that would constitute a major change
or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, another de novorequest
or even PMA approval.

Clinical trials

Clinical trials are almost
always required to support a PMA or a de novorequest, and are sometimes required to support 510(k) submissions. All clinical investigations
of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption,
or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array
of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant
risk” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which
must become effective prior to commencing human clinical trials. If the device under evaluation does not present a significant risk to
human health, then the device sponsor is not required to submit an IDE application to the FDA before initiating human clinical trials,
but must