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Industry stakeholders lauded the FDA’s efforts to make greater use of real-world data and to take a total product lifecycle approach to regulation as outlined in its proposed Medical Device Safety Action Plan. Read More
The UK’s Department of Health and Social Care (DHSC) released a contingency plan in anticipation of a possible “no deal” Brexit situation that could… Read More
In cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will provide a “substantive summary” of the failures identified. Read More
In 2017, the agency approved 66 devices through the premarket approval and humanitarian device exemption pathways but only 18 of those were indicated for use in a pediatric population. Read More
In preparation, the department analyzed supply chains for medical devices and clinical consumables to determine the proportion of products that are routinely imported. Read More
The agency said it would consider the target patient population, size, intended use and current treatment options in assessing devices for the HDE program. Read More
Manufacturers must make eIFUs available on their websites easy to navigate and search and not require users to create an account to access them, the agency said. Read More
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility. Read More