Reporting from Proposed FSMA-related Audits Raises Concerns

Reporting requirements from third-party audits drew many questions from stakeholders at the agency’s public meeting on proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies, held in Washington D.C., September 19-20.

As you may know, the objective of the accreditation proposal is to strengthen foreign food safety audits – although the agency has indicated that it would consider a similar approach for third-party audits conducted in the United States.

The accreditation rule calls for reports to be submitted to FDA on conditions found in an audited facility that might lead to a serious risk to health. Participants in the public meeting sought assurances from the FDA officials — including Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor –that this would only be a requirement for a regulatory audit, and not for a purely consultative audit conducted for the purposes of assessing compliance ahead of time. If FDA requires reports from consultative audits, it could cause companies to avoid this type of audit entirely, with the unintended consequence of reducing the number of audits conducted, stakeholders warned. Or, if FDA-accredited auditors had to report findings from consultative as well as regulatory audits, it would encourage companies to seek consultative audits from non-accredited firms. So there are many possibilities for unintended consequences.

Taylor assured participants at the public meeting that the agency wants to be very clear about reporting requirements and when they will and won’t be required. It doesn’t, for example, want to drive companies away from using FDA-accredited auditors in order to protect themselves from reporting requirements, he said.

Consumer groups are concerned that the agency may extend the third-party accreditation program beyond its intended application to imported food and they point out that this was specifically excluded during the deliberations by lawmakers leading to the enactment of FSMA. They view regulatory audits as the domain of the regulatory authorities and not the business of private auditing firms. This policy issue has been debated for many years – and not just with regard to FDA.

Interestingly, the requirement for inspections conducted by certified third-party auditors is limited to only two situations:

  • Imported food determined to pose a safety risk and requiring certification by FDA as a condition of granting admission into the U.S.
  • Issuing foreign facility certifications that will be used by importers to establish eligibility for the Voluntary Qualified Importer Program.

Importers who rely upon third party audits as part of their Foreign Supplier Verification Program are not required to use accredited third party auditors. However, FDA believes that there will be much broader adoption by the food industry of third-party audits performed by auditors certified by FDA-recognized accreditation bodies.

It seems to me that an effective policy must take account of what is possible in practical terms. By this measure, a preventive approach using third-party audits is the only viable option and it is preferable to the alternative, which is likely to be paralysis and no improvement in food safety measures for imported food.


Distinguishing Medical Device Recalls

By EAS Senior Consultant Paul F. Tilton

Do you know when a product enhancement is considered to be a recall in the eyes of the Food and Drug Administration? If not, I draw your attention to the draft guidance from FDA entitled Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements. Using plain language and a flow chart, the Guidance offers FDA’s perspective on the differences between the two. It was distributed for comment on February 22, 2013. The comment period ended in May, and FDA is now considering the comments received. I recommend that firms consider this guidance and seek consultation if necessary before making any changes in device design, labeling or manufacturing processes.

I speak with some experience. For twelve years I was a chief of the Ob/Gyn, Gastroenterology and Urology Branch, in the Division of Enforcement, Office of Compliance (OC), Center for Devices and Radiological Health (CDRH). Prior to my retirement in early 2012, certain steps taken by my branch in coordination with others in CDRH were instrumental in the genesis of this document. Let me explain. We became aware that a manufacturer had proposed a design change in a marketed device via the Premarket Approval (PMA) supplement process. Concurrently, we noted that several adverse events involving the same device had been reported through the Medical Device Reporting (MDR) system. Was there a connection?

After in-house (i.e., CDRH and the FDA district office) discussion, we opened dialogue with the manufacturer and shared points of view. The firm acknowledged the original design of the device might have been a contributing factor to the injuries reported via the MDR process, but concluded, nevertheless, that the design change was a product enhancement and a recall was not warranted. We expressed the need for a voluntary recall because of the seriousness of the health hazard, the likelihood of recurrence and other aspects.

This was not a unique situation. Quite often we encountered similar situations requiring meetings with manufacturers to clarify expectations. In this case, as always, we worked closely with the recall coordinator in the FDA district office and engaged the manufacturer only after having an FDA Health Risk Assessment in hand and the support of experts from OC, the Office of Device Evaluation (ODE), the Office of Surveillance and Biometrics (OSB) and others.

In the above situation, the Center’s point of view prevailed, and the manufacturer agreed to conduct a voluntary recall. Once that matter was settled, the firm asked to meet with us to get a better understanding of FDA’s processes to avoid similar problems in the future. We welcomed this discussion and recognized the need for a Guidance document.

The Guidance includes: 1) definitions of terms, 2) identification of what a recall is and isn’t, 3) clarification of violative and non-violative devices, 4) a recall decision making flow chart, 5) recall reporting requirements, and 6) product enhancement reporting requirements. It also discusses associated regulations, including 21 CFR 803 (Medical Device Reporting) and 21 CFR 806 (Reports of Corrections and Removals). A Q&A format is used throughout.

The Guidance is still in draft form and may change somewhat to reflect the comments received. But for now it is of value for helping to understand FDA’s perspective on device recalls versus product enhancements.