FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

The Food and Drug Administration (FDA) to withdraw said one of his drivers to audit progress in the implementation of a program fee "fully operational" in medical devices Individual control (MDSAP) in 2017.
FDA announced changes in the Federal Register Thursday, saying it "will not accept ISO 13485. 2003 Presentations formless voluntary audit After March 31, 2016 To Help Transition one MDSAP fabless"

ISO 13485: 2003 Pilot Presentation

In 2010, the FDA issued a draft Guidance paragraph describing a pilot program has allowed the companies perform other audits Working Group Global Harmonization Task Force (GHTF) Members meet para Founders Program Requirements Compliance Medical Devices FDA. Guide the term be back soon more years, and the pilot program launched June 5, 2012.
Under the pilot project, the establishments classified as low risk on the basis of the audit reports submitted its eligible to be removed from work routine FDA inspection Year Plan of the United Nations, which could limit the number of audits Spending Establishment of a Dębe.

Pilot MDSAP

However, in October 2012, GHTF s'ha dissolved, and work is beginning on the Regulators Forum International Medical Devices (IMDRF) New Program to Develop, facilitate MDSAP for exchange between audit regulators.
In January 2014, Lanzo IMDRF three-year pilot project, which should be completed a final ProBAR 2016 Feasibility MDSAP para.
The Purpose of MDSAP is for verification of recognized organizations satisfy audits for all the regulators involved in the program requirements, including FDA, Therapeutic Goods Administration of Australia (TGA); National Health Surveillance Agency of Brazil (ANVISA); Health Canada; The Japanese Ministry of Health, Labour and Welfare and the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

MDSAP full in OPERATION

In September, the FDA issued a Mid Controller highlighting the progress made in paragraph Pilot MDSAP July 2015. According to the report the main drivers majority Objectives are Met s'han; However, the pilot had paragraph Problems attract participation from industry. Halfway through the pilot, only 45 production centers had applied to join the Far 330 pilots had expected.