Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutics, Deemed to be University, Chennai, India

Publications

• Review Article   
  Regulatory and Technical Aspects of Software as Medical Device (SaMD)
  Author(s): Nagalakshmi S*, Sangeetha Priya S and Aravind R
  
  Software is revolutionizing how doctors practice medicine, customers control their health, and patients and providers interact. Software that can perform advanced medical functions software as a medical device is a game-changing innovation in digital health technology (SaMD). SaMD may diagnose ailments, prescribe medications and offer clinical treatment recommendations. The US FDA, EU and Australia TGA also specified general platforms. To overcome the challenges while interpreting software product fits into the medical device framework, IMDRF has developed different guidance including risk based categorization to determine possible levels of premarket reviews and Real-World Evidence (RWE).) IMDRF plays a similar function in enabling the regulators to risk-stratify submissions and focus resources on products that pose the greatest risk to patient safety. While SaMD products are not new.. Read More»
  DOI: 10.37421/2167-7689.2023.12.358

  Abstract HTML PDF