The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]
Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems. The FDA thinks we can use these kinds of data […]
Many organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past. The […]
Artificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge amount of data that is collected every day in the health care sector. This blog provides an overview of the FDA action plan […]
Are you developing a device that performs a more effective treatment, incorporates novel technology, or is like nothing else on the market? If the answer is “yes” then the new FDA program for breakthrough medical devices may be your best regulatory option.
Are you a manufacturer of a medical device that is in the early stages of development interested in gathering clinical data in the United States? Your device design will likely change, but the information needed is best gathered through clinical experience as opposed to non-clinical testing.
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
The FDA Regulation of E-cigarettes aims to fill a technology regulation gap. Whether it’s the FAA and recreational drones or the USDA and the latest strain of genetically modified corn, widespread use of new technology is often followed by new regulation. And regulators have long struggled to keep pace with the seemingly endless stream of […]
Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices? Are you on it, are you ready, and what does it mean? This blog will help you understand what it means for you and your device.
The FDA is eager to show improvement of a performance self-assessment which revealed “a steady decline” of its premarket medical device approval program between 2000 and 2010. In a recent report on policies and initiatives, the FDA device arm (CDRH) claims it approves medical devices much faster than five years ago. The Agency also outlines […]
StarFish Medical recently worked with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, as part of our ongoing efforts to improve and train our quality practices. During our breaks, I spoke with Larry about life after the FDA, how firms can best prepare for regulatory submissions, and the new open nature of the […]
Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device accessories. I previously wrote about the general wellness draft guidance. This blog analyses the FDA medical device accessory draft guidance. In both cases, less regulatory burden […]