The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA Commissioner Dr. Scott Gottlieb’s announcement on the renovation to the 510(k) program1 and two new pilot programs initiated by FDA: the Quality in 510(k)...
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the Medical Device industry. For our blog this week, we are presenting a brief analysis of the data published by the FDA for the fiscal years 2015, 2016 and...
The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified agenda also made it to the FDA’s Fall unified agenda published in October 2018.1 The revision will replace the existing regulation in an effort to stay modernized...
The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s digital health innovation action plan, the pre-cert program was announced in July 2017, and...
Medical devices in the UK are regulated by the directives put forth by the EU, including: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Device Directive (IVDD) High risk medical devices are certified by an independent conformity assessment conducted by...
In a previous blog from a few months ago on the update in the De novo pathway, we shed some light on the prices introduced through the MDUFA IV for the De Novo process. Additionally, the blog discussed how the release of the FDA guidance...
EpiPen Shortage Kids are going back to school all over the country. For many kids, an EpiPen (epinephrine injection) is a necessary addition to their back to school list. Food allergies are an increasing public health concern that affects an estimated 4-6% of children in the...
Overview The opioid epidemic can be traced back to the late 1990s, when the medical community began to prescribe opioid pain relievers at a higher rate due to the information and reassurance they received from the pharmaceutical companies that patients would not become addicted to prescription...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Technology and health care have converged in the 21st century under the umbrella of what is known as digital health. What is digital health? The 21st century has seen the convergence of science and technology. This has resulted in the development...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Background The International Organization for Standardization (ISO) is a non-governmental entity...