FDA Medical Device User Fees (MDUFA) for 2024
On July 28, 2023, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024.[1] The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes the FDA to collect medical […]
Medical Device Quality Management: One Size Does Not Fit All
Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable regulatory requirements, most often the FDA’s quality system regulations (QSRs) or ISO 13485. But where do you begin with a medical QMS? We have worked to implement medical […]
New FDA Guidelines for Artificial Intelligence and Machine Learning in Medicine and Medical Devices
Are you developing cutting-edge technology using artificial intelligence (AI) or machine learning (ML) in medicine? Are the vague regulatory requirements for AI and machine learning in medicine challenging to decipher? If so, you will be thrilled that the FDA has released new artificial intelligence and machine learning guidance. The release of this draft guidance aims […]
Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s
Are you a medical device developer with questions about when and how to file for regulatory approval? Navigating the complexities of the FDA premarket approval process can be daunting. But it doesn’t have to be – with careful planning and a good understanding of Premarket Approval (PMA) and 510(k) requirements, you can ensure that the […]
Uncovering the Benefits of Third-Party Compliance Auditing
The importance of maintaining a high level of quality and compliance can’t be overstated for medical device companies. Failing to do so can put patients at risk, land you in hot water with regulatory agencies, and harm your reputation—which is why remaining compliant and having strong quality management systems are essential. Quality control and assurance […]
Uncovering Medical Device Industry Challenges
In 2022, the global medical device market was valued at approximately $536 billion and is expected to grow to approximately $773 billion by 2027 (1). With an aging population, an expanding reliance on therapeutic and rehabilitative treatments, and increasing rates of chronic disease, the demand for innovative medical devices isn’t going anywhere. Like any industry, […]
CE Marking for Medical Devices
Medical device companies are usually anxious to get their product to market – they want to start meeting their business goals and they want their innovation to start helping people. Before this can happen, it is critical, and required by law, to ensure you are complying with the strict regulations of the medical device industry […]
Using Regulatory Strategy to Reduce Medical Device Time to Market
Using Regulatory Strategy to Reduce Medical Device Time to Market According to recent estimates (1), the global medical device market is expected to grow from over $455 billion in 2021 to almost $658 billion in 2028. That means it’s a lucrative industry with limitless potential for new technologies and heavy competition. Time to market is […]
New Proposed FDA Medical Device Quality System Regulations
New Proposed FDA Medical Device Quality System Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical device approvals in the U.S., announced its intention to update current good manufacturing practice (cGMP) requirements of the Quality System Regulation (QSR). The FDA offered […]