FDA releases Details on Medical Device Single Audit Programm Pilot

In our News from 19 November 2013, we referred to FDA's participation to the Medical Device Single Audit Program (MDSAP) Pilot. Now, further details on this program addressed to manufacturers of medical devices have been released.

Beside the FDA, the respective regulatory authorities in Australia, Brazil and Canada are involved in the MDSAP. The Japanese regulatory authority is active as an observer.

The idea behind the program is to enable acceptation from all the participating parties of an audit performed by auditing organisations recognized by the MDSAP. A list of all accredited MDSAP auditing organizations has also been published. Now, the FDA has released details on the program in a kind of Question & Answer document. The document provides answers to legal matters - even individual answers from monitoring organisations involved - like for example:

  • "Does the MDSAP Pilot add requirements for the manufacturer? " The answer is no.
  • "What are the potential benefits for the manufacturer? " Among other things the answers are: less inspections - this is the first benefit mentioned. Moreover, another benefit presented is a more harmonised approach through the use of a standardised MDSAP audit model. According to the paper, the participant´ commitment to product quality and regulatory compliance as part of the program should be seen as a marketing advantage.
  • "How will audits be conducted under the MDSAP Pilot?" The different answers to this question provide links to other documents.

A very detailed Q&A document containing 29 pages addresses the MDSAP program. The beginning of a regular but optional single audit program is planned for 2017.

Read more details about the MDSAP here.

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