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In the past week, the FDA revealed the future plan for its inspectional activities. In addition, President Biden announced a new July 4 vaccination target. Please see details for these and other supply chain developments below:
On April 27, Medtech Insight posted an FDA document to a medical device firm, explaining the Office of Medical Device and Radiological Health Operations’ Remote Regulatory Assessment (RRA) program to determine medical device facilities’ compliance status. Under the RRA program, the FDA requests and discusses electronic documents through meetings with the facilities. Participation in an RRA is voluntary, and refusal to provide information requested during an RRA is not a refusal of an inspection under Section 704 of the Federal Food, Drug, and Cosmetic Act. RRA findings will be considered for future routine FDA workplans and will be a factor in deciding the need for an onsite inspection.