INSIGHT REPORT
Vol 3  #9 
November 2000

INSIGHT REPORT

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Several years ago, June 27,1997 to be exact, the USA and the European Union (EU) signed an MRA covering a variety of product sectors. These sectors included telecommunication, electrical safety, recreational crafts, pharmaceuticals, and medical devices. The Medical Device annex to the MRA became effective December 7, 1998, with an initiate 3-year transition period during which both sides would engage in confidence building activities.

During this 3 year period, the FDA and the Commission for the European Communities (CEC) were to establish a joint confidence building program. A program designed to provide sufficient evidence of the capabilities of the nominated Conformity Assessment Bodies (CABs) to perform quality system audits or product evaluations to the specifications of the parties. After this three-year period the Medical Device Annex (MDA) of the MRA would become operational, if the confidence building activities were successfully completed.

This MDA covers the exchange of quality system evaluation/inspection reports for all medical devices and pre-market evaluations for selected low to medium risk devices. A European CAB would be able to conduct inspections for all classes of device and 510(k) evaluations for selected devices based on FDA requirements for European device manufacturers who wish to market their devices in the US. Similarly, a US CAB would be able to conduct quality system or type-testing evaluations based on EU requirements for US device manufacturers who wish to market their devices in the EU.

In addition, there would be an alert system set up to notify each other when there is an immediate danger to public health. As part of the system, each party will notify the other party of any confirmed problem reports, corrective actions, or recalls.

Will this system work? Can the America public be sure that a CAB qualified to audit firms under the FDA guidelines will provide the same level of compliance when the companies they are auditing will be paying these CABs for the audit service?

Initially there were 15 companies applying to be considered as CABs. There are now 10 or 11 companies still willing to participate in this program. From my discussions with the FDA, at the present time there are only 4 CABs that have at least one auditor that has completed the initial training.

The FDA will then expect that the CAB's conduct audits and provide their findings to the FDA for their review.

Presently, foreign companies are audited for QSR compliance by the same US FDA investigators that would also inspect US companies. These audits are free to foreign companies. The FDA either notifies the foreign company that they have been found to be in QSR compliance or the foreign company receives a Warning Letter outlining the critical points found during the inspection. In many cases the issuance of such a Warning Letter limits their ability to ship products to the USA until the areas needing corrective actions have been addressed and re-audited by the FDA to assure compliance.

Once this MRA goes into effect, EU companies would have the ability to hire (yes, I said hire), a CAB to come in and conduct the audit rather than have a FDA inspector from the states come to the firm.

This CAB organization usually also has the ability to audit for ISO certification. So the same audit used for the FDA could also be used for their ISO audit.

Meanwhile in the USA, medical device manufacturers would have to continue to be audited by both the US FDA as per the regulatory requirements and, if they want to ship to Europe, to maintain their ISO certification and have the Certifying body audit them.

This concept of having an independent auditing company for hire conducting FDA type inspections presents some concern to both the US medical device manufacturer as well as to the American public.

How can we be sure that such audits for hire would provide the same level of compliance as an FDA audit? Would the CAB who would be hired by a company to conduct an audit, actually provide a negative report that could result in product being detained in at the borders in the USA?

If a company has a problem with a CAB what would prevent the CAB from being asked to leave and another CAB being hired to perform the audit?

How fair it is to US companies to have to deal with a trained FDA investigator conducting an audit instead of an ISO trained auditor? The FDA investigators are trained in the FDA legal system and its ramifications. They have the responsibility to protect the public as a civil servant. This is not true of any auditor for hire in Europe. Would a European medical device manufacture whose certifying body for ISO may also be hired to perform the FDA audit, then report negative findings on their client that would prevent shipping to the USA?

It may be wise to have these questions answered before this MRA could go into effect. It is understood that the FDA's budget is never big enough to support the compliance surveillance they would like and that there is a lack of capable investigators to audit all the companies. However, the effect of implementing this type of agreement could cause the one thing that the FDA has always worked hard to prevent - the hint of impropriety.

There are some major concerns going forward with this MRA and we all need the answers before it gets implemented.

Next Insight Report - The Presidential Election and what it could mean to the Medical device industry.

Next Month’s Insight Report –

         The next Insight Report Vol. 3 #10

• The Presidential Election and what it could mean to the Medical Device Industry

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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