EU to Observe IMDRF Single Audit Program

The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks.

Currently participating in the medical device single audit program are the U.S., Australia, Canada and Brazil, with Japan and the World Health Organization listed as official observers. EU participation had been delayed by logistical issues concerning differing standards among the 28-member states.

Specifically, EU countries can’t participate in MDSAP because every participant has to have confidentiality agreements with every other player, explained Kimberly Trautman, associate director for international affairs in the FDA’s device center. That means that agreements for each of the 28 nations would need to be negotiated individually — a daunting task, she said.

Still, Trautman observed, companies opting for MDSAP audits won’t necessarily need to submit to a separate European audit. So far, all third parties approved to perform audits are notified bodies that can perform EU auditing tasks as an appendage to the MDSAP audit.

Developing Countries

IMDRF and WHO are encouraging regulators in countries such as Tanzania and South Africa that are developing medical device regulations to adapt MDSAP standards rather than reinvent the wheel, said Trautman, who spoke at FDAnews’ annual device quality conference in Bethesda, Md.

Devicemakers interested in the process should talk to an accrediting body about replacing their next routine audit with an MDSAP audit, she said. “We don’t expect anyone to want an extra audit. The expectation is that people will convert scheduled inspections” to an MDSAP audit.

For companies that remained undecided, Trautman dangled these enticements: Because the audits aren’t performed by the U.S. government, their results aren’t public record — and there’s no Form 483 that can be requested via the Freedom of Information Act.

MDSAP Portal

Trautman also offered an update on the IMDRF IT portal, which will allow companies to access data from MDSAP audits. The FDA has provided $1 million to fund the effort over two years, but the agency can’t host the servers because Patriot Act rules make any data on U.S. government servers accessible to the government — a source of security and confidentiality concerns for many foreign governments, Trautman said.

IMDRF has approached the Pan American Health Organization about hosting the portal and expects an agreement in the near future, Trautman said. The Regulatory Exchange Platform, as the portal will be called, will include information on drugs and good manufacturing practice, as well as records of device audits.

MDSAP inspections for combination products that are regulated as drugs may be possible in the future, but this will be driven by industry demand, Trautman said, citing the complexity of adding drug GMPs to MDSAP’s device auditing process. Devicemakers who have gone through MDSAP audits will be able to share their experiences during a June 23 IMDRF meeting set to coincide with the midpoint of the pilot program.

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