Hello everyone!
It's the end of week 8 and we hope everyone is surviving! If you are looking for something to watch/listen to, there is a film that was brought up in our office that I would like to recommend: The Bleeding Edge (on Netflix). The Bleeding Edge is about how medical devices enter our lives, both as direct consumers and through our doctor's office. As a little bit of background from my own coursework, medical devices are regulated by the FDA via the Center of Device and Radiologic Health (CDRH), Center of Biologics Evaluation and Research (CBER), and Center of Drug Evaluation and Research (CDER). Devices are classified according to risk, with class I being the lowest risk and class III being the highest risk. The two key approval pathways for medical devices, discussed in The Bleeding Edge, are the 510(k) pathway and Pre-Market Approval (PMA) pathway. 510(k)s are typically used for class II devices, and PMAs are typically used for class III devices. For approval, the FDA's primary goal is to see the device is safe and effective. Each of these pathways have their pros and cons, primarily related to how stringent they are (ensuring safety) and how expensive (money and time) they are. Without saying anymore, I would highly recommend that you give it a watch!
*TW: some of the medical conditions are described very graphically and have significant physical and emotional impacts on the patients.
Enjoy your weekend!
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