In late November US FDA published an update to its Experiential Learning Program for reviewers. This is a hands on program where review staff spend time at external facilities including manufacturers and hospitals.
FDA continually reviews its training priorities and the latest update reflects the agency’s efforts to keep on top of emerging technologies as well as address long standing areas need.
The agency published eight priority areas:
- Biocompatibility testing – including decision making processes around test selection, use of in vitro vs. animal testing, application to nanomaterials, resorbables and evaluation of color additives
- Combination products – with emphasis on drug coated or drug delivery products.
- Emerging manufacturing methods – with focus on 3D printing and other additive manufacturing techniques and their associated validation challenges.
- Clinical trials management including starting and completing trials and the realities of the IDE process.
- Reprocessing and sterilization including the interplay between validation and labelling as well as the challenges of “unique sterilization methods”.
- IVD manufacturing across the board from pre-analytical devices such as collection tubes to reagents, instruments and point of care devices
- Instrument training (manufacturer or laboratory) familiarisation with medical instrumentation including laboratory instruments and diagnostic imaging.
- QSR 820 quality systems – including implemented quality systems and particular interest in medical imaging or radiology devices.
In essence this boils down to biocompatibility, clinical trials and a targeted training in manufacturing including the growth areas of IVDs and emerging manufacturing techniques such as 3D printing, as well as opportunities to see larger capital equipment items in their in use settings.
Biocompatibility has been a long running area of contention (with FDA guidances now 20 years old and the contentious 2013 draft revision still not finalised). So it’s pleasing to see the agency’s continued consideration of risk based approaches to biocompatibility testing and bringing this area to the top of its current priority list.
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