Introducing a Specialized CRO for FDA 510(k) Study Needs Bringing a medical device to market requires navigating complex FDA regulatory pathways for medical devices. These pathways—such as premarket notification (510(k)), premarket approval (PMA), and De Novo...
Key Areas of Focus for Manufacturers Under the New Guidelines FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) The FDA has recently finalized a rule about...
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
To advance health equity, the FDA has launched the "Home as a Health Care Hub” initiative. This initiative aims to transform the traditional home into a primary setting for health care. This forward-thinking approach recognizes the evolving landscape of medical care,...
The essay linked below was written almost exclusively by ChatGPT based on a series of requests and feedback I provided as the essay evolved. I was looking to understand better what may be the potential impact of emerging artificial intelligence (AI) technologies on...
When I first heard about the new artificial intelligence (AI) chat tool called ChatGPT (created and offered as a free research tool by OpenAI), I was excited to play with it. Social media was abuzz with others in professional fields who had identified ways that this...
When designing a survey questionnaire, there are guidelines to consider regarding its length, including: 1. The purpose of the survey If the survey is designed to collect detailed information from respondents, it may need to be longer to capture what is needed. 2....