Beginning June 5, 2012, the Food and Drug Administration (FDA) will allow medical device companies to participate in a pilot program that will allow firms to seek a one-year reprieve from FDA inspections by voluntarily submitting recent International Organization for Standardization (ISO) 13485 audit reports and additional data to the agency. The basic concept is that if the FDA is comfortable that the manufacturing site meets ISO quality standards, it can “leverage” (FDA’s term) off of those audits and allow the agency to focus its inspectional resources elsewhere. The pilot program is for two years. On March 19, 2012, the FDA issued a guidance document to describe its expectations entitled “Guidance for Industry, Third Parties and Food and Drug Administration Staff – Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.”
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