All CPD supplements articles – Page 2

Journal

Eluvia: a drug-eluting stent

2019-05-01T16:08:00Z

Peripheral arterial disease (PAD) affects around 8–12 million people in the US.[1] The strong association with ageing, tobacco smoking, and diabetes means that the prevalence of PAD will continue to increase in the coming years. Although 20–50% of patients with PAD are asymptomatic, they are still at significant risk of ...

Journal

FDA regulatory pathways for medical devices

2019-05-01T15:59:00Z

The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.