Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 168

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 168
---
 with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the
promotion of investigational devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical
study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously follow the investigational plan
and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,
including a belief that the risks to study subjects outweigh the anticipated benefits.

Expedited development and review
programs

Following passage of the 21st
Century Cures Act, the FDA implemented the Breakthrough Devices Program, which is a voluntary program offered to manufacturers of certain
medical devices and device-led combination products that may provide for more effective treatment or diagnosis of life-threatening or
irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and health care providers with more timely
access to qualifying devices by expediting their development, assessment and review, while preserving the statutory standards for PMA
approval, 510(k) clearance and de novoclassification. The program is available to medical devices that meet certain eligibility
criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases
or conditions, and that the device meets one of the following criteria: (i) the device represents a breakthrough technology, (ii) no approved
or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv)
the availability of the device is in the best interest of patients. Breakthrough Device Designation provides certain benefits to device
developers, including more interactive and timely communications with FDA staff, use of post-market data collection, when scientifically
appropriate, to facilitate expedited and efficient development and review of the device, opportunities for efficient and flexible clinical
study design, and prioritized review of premarket submissions.

Post-market regulation

After a device is cleared
or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:

  establishment registration and device listing with the FDA;                                                                                                                                           
  QSR requirements, which currently require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures ...  
  labeling regulations and FDA prohibitions against the promotion of investig