FDA has announced that its planned guidance for device makers to voluntarily submit ISO audit reports has been delayed. The agency hopes to release it before the end of the year. What are your thoughts?
Nicolaas C. Besseling, BesTech Consulting Services: The provision to voluntarily submit ISO audit reports was part of the MDUFMA 2007, so it's been law for more than one year now. FDA has had difficulties before when supporting or implementing new sections of the law, and I do not have insight into any realistic timeline for this particular issue. I have noticed, however, that many field inspectors are unfamiliar with the provisions of ISO 13485, and part of an effective guidance is to have the field personnel properly educated. I tend to be skeptical about the timeline.
What do device manufacturers have to gain by voluntarily submitting ISO audits to FDA. Will they be less likely to face an FDA inspection?
Besseling: FDA is not clear about that. In deciding who to audit "next," the agency claims it will take an ISO audit into account, but its does not specify how. In theory, however, FDA would not have to re-audit those areas of the device manufacturer's quality system that are adequately covered by ISO 13485:2003. How well this theory is converted into practice remains to be seen.
Will FDA accept audits conducted by all bodies authorized to do ISO audits?
Besseling: I speculate that the credibility of notified bodies will be built up over time as FDA gains experience with this process. Initially there will probably not be too much favoritism.
AdvaMed President Steve Ubl has urged Congress to amend the law to allow FDA to accept the ISO 13485 international quality system standard as equivalent to its Quality System Regulation. Do you think this has traction? What are some of the challenges that may prevent this from happening.
Besseling: In theory, this sounds like an excellent idea. However, the current FDA/QSR law has several requirements that are not covered in ISO 13485, in particular with respect to quality records. If such an initiative is taken seriously, it may involve major negotiations between FDA and industry. This will take years. The current QSR is well-understood and widely implemented, whereas in the United States ISO 13485 is the exception rather than the rule.
After 22 years leading medical equipment design and development teams at world-class firms such as Siemens Medical Solutions, Nicolaas C. Besseling started BesTech Consulting Services to provide regulatory consulting services to medical device companies. Besseling focuses on helping companies to comply with FDA’s Quality System Regulation (QSR) for US compliance, ISO 13485:2003 for European compliance, CMDCAS for Canadian compliance, and related issues. He frequently submits product(s) to the relevant authorities for approval or clearance, such as 510(k) clearance or CE mark.
The majority of BesTech’s clients are small to medium-sized companies that require a personalized approach to resolving problems. Because of his background in the design and manufacturing of medical devices, Besseling brings a unique set of skills to shuttling products from the napkin stage to end use, all within a regulatory compliant framework. These skills include writing and implementing complaint-related standard operating procedures, setting up product documentation that will withstand ISO and FDA scrutiny, and helping companies to organize operations. In addition, Besseling can define and implement product testing needed for regulatory approvals.
For more information about his company, view its listing in our online Consultants Directory or go to the firm’s Web site at www.bestechconsulting.com.