Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered personal protective equipment (PPE) that helps in preventing exposure to particulates that spreads infectious diseases. A face shield...
Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week...
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...
As several PPEs, Ventilators, test kits, and other devices have been on the US market for quite some time now under the EUA program, the FDA outlined its expectations surrounding adverse event reporting for these medical devices. 1 FDA released a...
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...