Medical Devices

The EU Commission committed to provide information on the availability and the capacity of the notified bodies to conduct conformity assessments in the Joint European Roadmap towards lifting COVID-19 containment measures released on April 15, 2020.1 The EU commission conducted...

The medical device industry is constantly looking for innovative new ways to treat and cure conditions. Last month, the FDA permitted marketing of the first-ever game-based digital therapeutic device aimed at treating children with attention deficit hyperactivity disorder (ADHD). The...

The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to standalone software regulated as a device. The UDI Rule also requires that data pertaining to the key characteristics of each...

Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement of the FDA Reauthorization Act (FDARA) of 2017. The FDARA was signed into law on August 18, 2017, and amends the Federal Food, Drug, and...

FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of the pandemic on their pre-market submissions made to the FDA. As per this guidance, FDA says the...

The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever done. Relaxed regulations allow quick access to critical medical devices necessary to fight the pandemic, but what will happen to the medical...

When COVID-19 caused the Commission to delay the MDR date of application by a year (May 2021), it was advised that the extra year be spent ensuring compliance with the new regulation. As the pandemic continues to pose an obstacle...

FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical supplies during this public health emergency. On May 21,2020, FDA released another temporary policy that allows manufacturers of devices cleared under a Pre-Market...

The EU commission released a guidance document this week that explains the commission’s policies for transitioning of CE certificates for combination products and for devices manufactured using animal tissues under the medical device regulations. Under the Medical Device Directives and the...