The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The hot issues are related to compliance, EU MDR and recalls.
The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.
With May 26, 2020 quickly approaching, every day counts.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.