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...
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...
The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home sample collection kits for COVID-19 tests. EUA’s are the FDA’s provision which allows the use of unapproved medical products when there are no...
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach regarding cGMP’s and inspections. This new program was released as part of an update to the Compliance Program Guidance...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...