On 07-Apr-2020, Olympus announced the approval of its non-surgical medical device, iTind for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). FDA has provided a De Novo classification for this product and classified it under Class II medical device category. It is a temporarily placed urethral opening system for symptoms of benign prostatic hyperplasia.…
The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention. Class I medical devices are “considered safe” which does not…
Types of regulatory approvals: The following types of regulatory pathways are used for to avail USFDA approval for commercialization of a medical device into market. Premarket notification (510(k)): This regulatory pathway is a fast track system used for devices which do not require any clinical data and are substantially equivalent to a predicate device (similar…