Understanding the Medical Device Classification and Approval Process – Part One
Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval
Stem Cell Therapies and Clinical Trials
Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.
Stem Cells Therapy Clinic Startups – Legal Compliance Issues
The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.
Healthcare Compliance Issues for 3D Printing Medical Devices
3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.
Mobile Medical Image Analysis – Part Two
We review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical [...]
Medical Image Analysis Software – Part One
New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.
What are Mobile Mental Health Apps and How Are the Apps Regulated? Part Two
What mobile mental health app manufacturers and the physicians who recommend and use these apps need to understand about FDA regulation of medical devices.
Digital Health and FDA – Part Two
Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial [...]
Digital Health and FDA – Part One
The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]
Immunotherapy and Healthcare Compliance
Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.
