Zdrowie i gospodarka · 28/04/2003

Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties; Availability

The Food and Drug Administration (FDA) is announcing the criteria it will use to accredit persons for the purpose of conducting inspections of eligible device manufacturers under section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which established an "inspection by accredited persons" program. The new law requires FDA to publish in the Federal Register the criteria it will use to accredit persons to conduct inspections of eligible device establishments. These criteria are set out in this document and will become effective immediately after approval by the Office of Management and Budget (OMB) of the collection of information proposed by FDA in connection with this program. At that time, FDA will begin accepting applications for this program. In this document, FDA is also announcing the availability of a guidance document that will provide information for those interested in participating in this newly-created program. The guidance is entitled "Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff and Third Parties." In ac