15/16 February 2022
Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices. After having conducted together with the industry a detailed analysis of quality metrics with regard to medical devices, the FDA started 2011 CfQ. At that time, one of the outcomes of the analysis pointed out that companies with a company-wide quality organisation received fewer complaints - both internal and external - and had fewer quality costs compared to their business rivals.
Since 2011 the deficiencies observed by the FDA during inspections have been remaining constant year after year. The Warning Letters statistics show the same outcome. This is the reason why the FDA now wants to take a different path within the framework of CfQ in order to take quality enhancing measures regarding medical devices. To achieve this goal, the FDA plans 3 measures:
1. Focus on quality - concerning this point, there are parallels to medicinal products. (Quality) metrics - relevant for medical devices - should be identified. In the medium term, these values should be used as rationales in the context of frequency of inspection. One can see here parallels to the Quality Metrics Initiative for medicinal products.
2. Involvement of stakeholders: Informative and meaningful feedback should be achieved through a close collaboration between the industry, hospitals, patients, etc.
3. Data transparency: quality relevant data - like e.g. recalls and inspection outcomes which may be published - should also be released in an evaluable way.
These analyses should enable the industry to concentrate on the areas which have the strongest influence on product quality and thus on product safety. Thereby, metrics and successful quality practices should be brought together to ensure quality enhancing measures in the patients' interest.
You will find more detailed information in the FDA Voice article entitled "The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients".