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A Step-by-Step Guide to Performance Evaluation for IVD Devices by Operon Strategist

Performance evaluation is a crucial step in the development and validation of in vitro diagnostic (IVD) devices. It ensures that...

BD, a global medical technology company, has recently announced its expansion of access to advanced image-enabled, spectral cell sorters. This...

Greenlight Guru Clinical is a leading provider of quality management software for the medical technology industry. Their platform offers a...

Greenlight Guru, a leading provider of quality management software specifically designed for the medical device industry, has once again proven...

Managing budgets and meeting milestones are crucial aspects of conducting successful clinical investigations in the field of medical technology (MedTech)....

The National Medical Products Administration (NMPA) in China has been busy in April 2024, with several important updates and developments...

The Food and Drug Administration (FDA) has recently announced that it will be clearing Bluetooth medical devices for use in...

The Food and Drug Administration (FDA) has recently announced that it will be clearing the use of Bluetooth technology in...

The National Medical Products Administration (NMPA) recently issued a new guideline aimed at improving usability engineering in medical devices. This...

The National Medical Products Administration (NMPA) in China recently issued a new guideline for usability engineering in medical devices. This...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets for growth...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets to tap...

Sequana Medical, a leading medical device company focused on the development of innovative solutions for the management of fluid overload...

Introduction ISO 13485:2016 and Part 820.25 are two important standards that govern the quality management systems of medical device manufacturers....

Healthcare cloud computing has revolutionized the way medical devices are managed and operated in the healthcare industry. By utilizing cloud-based...

BioCardia, a leading biotechnology company focused on the development of innovative regenerative therapies for cardiovascular diseases, has recently received a...

ElectroCore, a leading bioelectronic medicine company, has recently been awarded a grant to further develop a groundbreaking treatment for post-traumatic...

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical products in...

Drug-device combination products are becoming increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Haryana, one of India’s leading states in terms of industrial development, has recently announced its ambitious Medical Device Manufacturing Policy...

Colorectal cancer is a type of cancer that starts in the colon or rectum, and it is the third most...

Drug-device combination products have become increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Vapotherm, a leading global medical technology company, is set to introduce its latest innovation, the Access365 Home Ventilation Solution, at...

Medtronic, a global leader in medical technology, recently announced a strategic shift in its approach to ventilators in response to...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Sysmex Corporation, a leading global healthcare company, has been making waves in the field of robotics with its innovative approach...

The INHALE-3 study, a groundbreaking clinical trial comparing the efficacy of Afrezza® with traditional insulin delivery methods, has recently released...

Genesis MedTech, a leading medical technology company, has recently announced a partnership with Silk Road Medical to improve healthcare access...

Genesis MedTech, a leading medical technology company, has recently announced a partnership with Silk Road Medical to improve healthcare access...

Starting April 1, RF Aesthetic Equipment will need a Device Certificate

Starting April 1, RF Aesthetic Equipment will need a Device Certificate

As of April 1, 2022, all Radio Frequency (RF) Aesthetic Equipment will be required to have a Device Certificate in order to be legally sold and used in the United States. This new regulation is being implemented by the Food and Drug Administration (FDA) in an effort to ensure the safety and effectiveness of these devices.

RF Aesthetic Equipment is commonly used in cosmetic procedures to tighten skin, reduce wrinkles, and improve overall skin tone. These devices use radio frequency energy to heat the skin and stimulate collagen production, resulting in a more youthful appearance.

In order to obtain a Device Certificate for RF Aesthetic Equipment, manufacturers will need to submit a premarket notification (510(k)) to the FDA. This notification must demonstrate that the device is substantially equivalent to a legally marketed device and meets all applicable safety and performance standards.

Once a Device Certificate is obtained, manufacturers will be required to include specific labeling information on their products, including the intended use of the device, any contraindications or warnings, and instructions for use. This information will help ensure that healthcare providers and consumers are aware of the proper use and potential risks associated with these devices.

Healthcare providers who use RF Aesthetic Equipment will also need to ensure that they are using devices that have a valid Device Certificate. This will help protect patients from potential harm and ensure that they are receiving safe and effective treatments.

Overall, the new requirement for RF Aesthetic Equipment to have a Device Certificate is a positive step towards improving the safety and quality of these devices. By ensuring that manufacturers meet specific standards and provide accurate labeling information, the FDA is helping to protect both healthcare providers and consumers.

In conclusion, starting April 1, 2022, RF Aesthetic Equipment will need a Device Certificate in order to be legally sold and used in the United States. This new regulation will help ensure the safety and effectiveness of these devices, ultimately benefiting both healthcare providers and consumers.