Article preview from "The Gray Sheet"- January 23, 2012
Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.
Article preview from "The Gray Sheet"- January 23, 2012
An easy-to-miss footnote to FDA’s recent 510(k) program draft guidance is attracting the attention of some industry experts as a potential overstepping of agency authority.
The language in question, tucked into the 40-plus-page document issued last month, could create a new requirement for nonclinical studies performed in support of 510(k)s, stakeholders say.
As the draft guidance explains, FDA frequently relies on preclinical data from mechanical, engineering, biocompatibility, laboratory and animal studies to show that a new 510(k) device is as safe and effective as another similar device already on the market.
In footnote 34, FDA states that all nonclinical laboratory studies supporting the safety of medical devices must comply with the agency’s “Good Laboratory Practices” (GLP) regulation, and that any nonclinical lab study submitted as part of a 510(k) “should include a statement that all nonclinical laboratory studies were conducted in compliance with 21 CFR Part 58.” Or, firms should explain why they did not comply with GLPs, FDA says.
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