SRA's number for the day: 572
This article was originally published in SRA
The US Food and Drug Administration receives up to 572 medical device protocols involving pediatrics every year1.
The figure is based on the average number of applications or submissions, including supplements, reviewed by the FDA's Center for Devices and Radiological Health per year and an estimate on the per cent of medical device applications involving children.
The FDA released this figure on 26 February, when it made substantive changes to a 2001 interim rule on providing additional safeguards for children participating in clinical investigation of drugs, medical devices and other products. The new rule will start applying from 28 March.
In 2001, the agency received 170 medtech pediatric protocols. Since then, such submissions have ranged between 305 and 572 per year, it said. These medtech pediatric studies, as well those involving drugs, biologics, food and food additives involving children (totaling around 872 to 1,227 per year) will be affected by the new rule.
References
1. Federal Register, 26 February 2013, 78(38), 12937-12951, www.gpo.gov/fdsys/pkg/FR-2013-02-26/pdf/2013-04387.pdf