Approval is the beginning of the evidence, not the end of it. Post-market surveillance is how regulators and manufacturers find out what a product does in wider use, over longer periods, in people who would not have qualified for the trials.
Our reporting covers how surveillance systems detect problems, how long they take, and what a recall or a label change means for people already using a product.
Medical devices explained: what counts as a device, risk classes, how FDA and EU MDR regulation works, software as a medical device, and post-market surveillance.
How medical device innovation works: needs identification, prototyping, design controls, risk management, clinical evaluation, regulatory approval and adoption.
What the FDA does: regulating medicines, biologics, medical devices, food and tobacco, how review and inspection work, its centres, powers and known criticisms.
How medical device regulation works: risk classification, FDA pathways, EU MDR and notified bodies, clinical evidence, software rules and post-market surveillance.