Medical device industry ensures that users can use medical devices safely, effectively, and efficiently.. Creating Instructions for Use (IFU) for medical devices requires quite a lot of responsibility. It requires a combination of technical communication skills with project management, administrative and legal skills.

IFU is not something that can be referred to in many ways, such as a user guide or an operation manual. It is a document that is instrumental in achieving safety for a medical device and is therefore considered a part of the product user interface.

The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans. The global Health Authorities, along with various healthcare providers, were pushed to transform their operational models overnight to deal with the on-going crisis.

The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic. A lot of temporary changes have been made to the regulations of various medical, medicinal and cosmetic products, such as vaccines, PPE kits, surgical masks, hand gloves, hand sanitizers, etc., to expedite their approvals and market entry, and to meet their market demand.

In December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.

Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.