Because of the virus COVID-19, FDA is postponing the majority of foreign inspections to a later date, exception made for those considered “mission-critical”, that will be considered case by case.
A pilot program for MDSAP remote control is defined.
FDA states to have alternative methods to keep on doing inspections, as:
- to deny the entry of unsafe products into the United States;
- to carry out testing on samples of devices at the borders of the United States before the importation;
- to review the previous history of compliance of a company;
- directly request system documentation and records.
Accordingly, a specific procedure to define a pilot program on the remote control of the processes and MDSAP requirements as part of the audit of the organization has been published.
The estimated duration of the pilot program is 18 months from the date of the procedure approval, but it can be interrupted before or extended by the MDSAP experts team.
The remote control can be used during the initial, surveillance and re-certification of the Stage 2 audits and it needs the specific indication of some information related to the type of technology to be used during the audit (ex. videoconference), the team of assigned auditors and the definition of an appropriate working space.
During the pilot program the reference data are available on the FDA website so that the Regulatory Authorities can evaluate if the experience is positive and satisfies the MDSAP requirements.
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