A medical device manufacturer approached Elexes with a High-Intensity Focused Ultrasound (HIFU) device intending to be placed in the US market. The device is capable of delivering HIFU energy that disrupts subcutaneous adipose tissue (SAT) and provides a non-invasive approach to achieve the desired aesthetic effect. The device aims at non-invasive waist circumference reduction. The manufacturer required assistance in figuring out testing and clinical requirements of the FDA subjected to their device. Elexes, through its comprehensive due diligence, confirmed that this device falls under Class II and the regulation number was 21 CFR 878.4590 — Focused ultrasound stimulator system for aesthetic use. Also based on the availability of predicate devices in the market with similar intended use and principle of operation, it was determined that the device is eligible for a premarket notification — 510(k) submission.

Problem Statement:

• Roadmap for FDA Clearance­

As the manufacturer was not based out of the US, they were not well acquainted with the regulations and policies of the US FDA. Hence the manufacturer required clarifications on the pathway to commercializing their device in the US market.

• Figuring out appropriate test requirements

The manufacturer sought to determine testing requirements for their ultrasound device based on applicable standards and country-specific regulatory requirements.

• Concerns in Clinical Study requirements

The manufacturer had performed clinical studies in OUS (outside-US) sites and was unsure if that data was sufficient to be accepted by the FDA. Also, the manufacturer was looking to register the study at clinicaltrials.gov and get the NCT number, which the manufacturer mistook for an obligatory submission requirement.

Solutions:

Elexes proposed the following solutions after analyzing the manufacturer’s objectives and the evidence:

1. Roadmap for FDA clearance — Comprehensive regulatory due diligence.

Based on the product analysis, Elexes found devices with a similar principle of operation hence the manufacturer can proceed with a 510(k) submission.

1. Identifying testing requirements — Listing down the applicable regulatory standards and country-specific requirements for the ultrasound device.
2. Clinical study requirements — Comment on the clinical studies, if FDA would accept studies performed at OUS sites.

Approach:

Roadmap for FDA Clearance — Comprehensive Regulatory Due Diligence

Elexes performed extensive regulatory due diligence based on a complete analysis of the product and strategized the regulatory pathway. As a result of several brainstorming sessions, Elexes concluded that the device falls under Class II and will need a 510(k) clearance. Elexes generated a due diligence report with a roadmap for clearance, which included specifics such as:

Identifying testing requirements

Elexes conducted a complete evaluation and analysis of the product by leveraging all the relevant information about the device such as its intended use, intended purpose, functionalities, usability features, safety controls, target population, etc. The following testing requirements were identified:

Clinical Study Requirements

Elexes regulatory and clinical experts assured the manufacturer, that the FDA would accept trials conducted outside the US. However, it was clarified that the NCT number is not a mandatory prerequisite for 510(k) submission.

Key Takeaway:

Joining hands with industry experts at Elexes, possessing strong quality, regulatory, and project management experience, the medical device manufacturing company successfully conducted the necessary level of testing. Elexes resolved all the queries from the manufacturer on placing the device in the market within the short stipulated time frame. This enabled the manufacturer to pre-pone their expected date of market launch.

Performing efficient regulatory due diligence and selecting an appropriate pathway is the most significant step in placing the device in the designated market. Irrespective of its risk classification, with the right strategy and strong interpretation of applicable requirements, attaining the market is always hurdle-free and smooth for any medical device, saving man-hours and costs.

Would you like to place your device in the US market?

Elexes is here to help you. Our dedicated team has years of experience in supporting our clients in this process. Please contact us at jennifer@elexes.com or call +1 650–503–6615 to have us review your device as per FDA regulations and guide you through the corresponding next steps.

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