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Devicemakers will need to include in their license applications performance testing data that “clearly demonstrates that the infusion pump can… Read More
The FDA said it would explore whether it has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling currently required. Read More
The Philippines Food and Drug Administration issued a warning that the Johnson & Johnson First Aid To Go Kit includes devices that have not gone through the registration process and are considered counterfeit and unapproved devices. Read More
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