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"The global hand dryers market size is expected to reach USD 1.7 billion by 2025, expanding at a CAGR of 11.5% from 2019 to 2025. A key factor contributing to the marketgrowth is decrease in oil and gasoline reserves. Over 464 gallons of oil and 42 gallons of gasoline are used to make one ton of paper towels. Hand dryers reduce the usage of gas and fuel and contribute towards greener solutions. Demand for these products is increasing as it helps in eliminating the mess caused by the usage of paper towels, thereby improving the restroom appearance."

"The global pharmacovigilance market size is expected to reach USD 11.64 billion by 2026. It is projected to expand at a CAGR of 13.3% during the forecast period. Increasing incidence of Adverse Drug Reactions (ADR) is the key growth driver. The U.S. Food and Drug Administration (FDA) received approximately 253,017 serious adverse events and 44,693 deaths associated with ADRs in 2015. This shows the potential demand for implementing safety and Pharmacovigilance (PV) services."

Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.