A little-noted provision in revisions to ISO 13485 could force manufacturers to collect a mind-boggling amount of additional data, an FDA official warns.
As drafted, the revised version would require manufacturers to keep records documenting the supply chain for every device component from manufacturer to end user, a change FDA Associate Director of International Affairs Kim Trautman says would be overly burdensome and expensive. U.S. regulations generally stop at the initial purchaser, she told conference-goers at MedCon 2015 in Cincinnati on Wednesday.
Scott Sardeson, international regulatory manager at 3M Healthcare, says the revision is meant to more closely align the U.S. with Global Harmonization Task Force recommendations on risk-based quality management. New sections include standards tied to approval and monitoring of suppliers, as well as an expanded section on human resource factors that could affect device safety. The draft also adds a checklist on auditing techniques and discusses a unique device identifier requirement, though it doesn’t call it UDI.
The draft would also add to postmarket feedback requirements by mandating that manufacturers actively gather data — for example, searching social media for complaints, Sardeson says. And a new section on complaint handling has been added and sections on corrective and preventive action clarified.
Trautman believes the draft needs further revision before it is finalized. For one thing, it calls for investigators to categorize nonconformances down to a fourth or fifth decimal level (e.g., standard 126.96.36.199), while international standards call for a three-level nonconformance categorization. The latter should be maintained to ease the burden on regulators and limit the risk of coding error, she says.
In addition, the current draft has pushed several suggestions and best practices into subsections called notes.
Trautman fears some inspectors may incorporate the notes into audits and dock devicemakers who don’t follow them, violating the key goal of consistency. “If there’s something we want devicemakers to do, it should be required,” Trautman says. “If it’s not, we should leave it out of the standard.”
The International Standards Organization is expected to discuss the draft in Denver, Colo., in June, and Sardeson anticipates at least two more meetings will follow before it is finalized. While comments are officially closed, manufacturers can contact the FDA or ISO with their thoughts.
The goal is for the revised standard to be approved by the first quarter of 2016 and take effect by 2019. — Elizabeth Orr