23
Jul
US tariffs 2024: How Medical Device Businesses Can Leverage New Opportunities
The year 2024 brings new challenges and opportunities for the global medical device market. One significant change is the increase in tariffs on medical devices imported into the US, particularly from China. This shift opens doors for non-US medical device businesses to expand their reach and fill the gap. Increased US Tariffs 2024 on Medical […]
04
Mar
What is Premarket Approval (PMA)? – The difference between FDA (510k) and PMA
When launching a new medical device to the market, manufacturers must comply with the strict regulations of the U.S. Food and Drug Administration (FDA). The two most common processes are PMA (Premarket Approval) and 510(k). In this article, GOL will explain what PMA is, compare it to 510(k), and help you understand the appropriate process […]
16
Jan
What is FDA 510(k)? Learn about the FDA 510(k) certification
The United States is one of the largest medical device markets globally. To be authorized to market medical devices in this industry, manufacturers must comply with the regulations of the Food and Drug Administration (FDA). One of the crucial regulations is the FDA 510(k) certification. So, what is FDA 510(k)? What are the regulations associated […]
16
Jan
FDA Medical Device Classification Guide: Classes I, II, III, Registration, and Audit Requirements (2026)
FDA medical device classification decides your pathway, timeline and costs. Classes I, II and III explained, plus how to register and list your device, the De Novo option, and how often the FDA inspects.
