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FDA Outlines Critical Quality Measures

3.  Draft CtQ indicators.

Rahman provides an example of a spinal implant, with key characteristics being sphericity and surface finish of the endplates. After pinpointing key characteristics, reviewers then evaluate the impact of failure. In this case, conformity of either of these characteristics can lead to excessive wear, which can lead to pain, metal debris inside the end-user’s body or the need for revision surgery. Then, reviewers talk about the controls.

“Sphericity is primarily an output of the CNC turning, CNC milling and deburring processes performed by the contract manufacturer,” Rahman said. “The contract manufacturer is key because when we reference 21 CFR 820.50, we’re referencing purchasing controls. That gives the investigator an indication that they should really look at the purchasing controls for this key characteristic. We also reference the quality system inspection technique, specifically production and process controls with respect to number two, [identifying the controls used in design and manufacturing] which is also tied into acceptance testing and supplier control.”

4.  When possible, validate the document with technical stakeholder input.

The fourth step is the most critical, as it assists FDA and the stakeholder in closing the perception gap on quality.

“We’ll go back to industry and make sure we’re on the same page—that the key characteristics we identified are also what they think is key,” Rahman said.

FDA recently launched a webpage for its Case for Quality Stakeholder Forum. The site highlights  projects that encourage operating above the quality system regulatory baseline, as well as a forum for engaging on this topic.

The forum, spearheaded by the Medical Device Innovation Consortium, allows stakeholders to discuss the latest quality measures and models. Meetings are held regularly to discuss the latest research and discourse on quality maturity models and quality measures.

Other initiatives on which MacFarland advised orthopaedic device manufactures to stay abreast include:

FDA Library of Quality Practices

FDA is working with stakeholder organizations, from standards organizations to industry membership organizations, to pinpoint quality best practices that firms should incorporate into design stages in order to take quality beyond baseline regulatory requirements.

“We’re getting away from the fundamental quality system concept and into the tools that can be used, so look for more on this concept in 2015,” MacFarland said.

Quality Measures Project

Recently, FDA completed a quality measures project with Xavier University to identify key indicators of product quality related to pre-production, production and post-production.

The results are now in the hands of the Medical Device Innovation Consortium, to further industry’s case for quality projects.

“Now they are taking all of that information from this effort over the last year and boiling it down to three measures of product quality,” MacFarland said.

Data Transparency

FDA seeks to ensure that information on product quality and quality system compliance is readily available for manufacturers. FDA has been working with third-party organizations to determine what data the Agency has, and what data should be made available to industry.

FDA representatives encourage industry to stay tuned for more announcements and information on these upcoming initiatives.



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