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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 Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.
Prevention of food safety issues has been a primary focus for the United States Food and Drug Administration (US FDA) over the past decade. To monitor and enhance food safety, FDA has introduced Food Safety Modernization Act (FSMA) in 2011, which emphasizes on all the aspects of food production, and supply chain; from farm to fork.
More than ever, consumers these days are concerned about their personal health and well-being and are keen on looking for informative product labels for correct usage. This has given rise to several trends in the food labeling industry.
In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content.
With 3,00,000+ Over-the-counter (OTC) products in the USA market alone, it is projected that, so far $105 billion have been saved in doctor visits, diagnostic tests and prescription medications. That makes us wonder, how come they be so cost-effective? Of course, it’s their ability to self-diagnose, self-treat, and self-manage and simple-to-use nature.
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k).
Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall.
North Africa & Middle East
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