FDA

On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly...

It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an implanted pacemaker and...

The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society...

For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a...

FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a list of regulatory science tools to help the industry in new product development. The Office of Science and Engineering Labs is a part...

As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice.1 However, Health Canada is using...

With the recent pandemic, one of the most crucial medical services is that of Digital Medicine. It is the merger of the medical device, pharma industries, and modern technology to better track and understand the physiological systems along with the...

Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22 and Clause 8.2.4 of ISO 13485:2016, but they are also fundamental in ensuring continuous review and improvement of a quality...