18/10/2024
On October 1, 2024, the FDA’s Centre for Devices and Radiological Health (CDRH) in the US announced that devices with a ‘Breakthrough‘ designation, as assessed by the Office of Radiological Devices (OHT8) and the Division of Ophthalmic Devices (DHT1A), are eligible to enrol in the Total Product Life Cycle Counselling Pilot Programme.
Medical Devices designated as ‘Breakthrough’ by the FDA (Food and Drug Administration) are innovative products that offer substantial improvements over already available treatment options. This designation is granted to devices that present significant advantages in terms of safety or efficacy and that meet medical needs not yet satisfied.
The CDRH launched the TAP pilot programme in 2023, as part of the commitment established in the reauthorisation of the Medical Device User Fee Amendments (MDUFA). The main objective of the programme is to stimulate faster development of high quality, safe and effective Medical Devices, essential for addressing public health needs. To date, the programme has involved around 50 devices with a ‘Breakthrough’ designation, reviewed by the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5).
TAP mainly aims to accelerate patient access to innovative Medical Devices by facilitating strategic and timely communication with the FDA. It also promotes the involvement of other stakeholders, such as patients, payers and healthcare professionals, during the design and development phases of products. A dedicated team of FDA advisors provides proactive and customised support to each participant, thus contributing to more effective promotion of the devices on the market.
In addition, the CDRH offers a useful resource for innovators and collaborators: the ‘TAP Pilot Engagement Tips‘. This guidance provides insights and recommendations to facilitate effective interactions between medical device sponsors and other stakeholders outside the FDA during the design and development phases.
Benefits for Manufacturers
Manufacturers participating in TAP can benefit from:
- Frequent interaction with FDA: frequent dialogue to solve problems and clarify regulatory aspects during the product development process.
- Accelerated market access: priority review for innovative devices, especially those with ‘Breakthrough’ designation.
- Collaboration with other stakeholders: TAP encourages collaboration between manufacturers, patients, payers and healthcare providers, which can improve device design and development.
- Support throughout the product life cycle: The FDA provides feedback and support to manufacturers from the development stage through to commercialisation, helping to ensure that devices meet regulatory standards.
These advantages enable manufacturers to develop safer and more effective devices aligned with market and public health needs.
>>> The experts THEMA and THEMA CORP based in the USA, are on hand to guide you through the right regulatory strategy to successfully market Medical Devices in the US market, throughout the product life cycle.
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