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Contractor Booz Allen Hamilton delivered its latest independent assessment of FDA’s device review program. Here are four under-the-radar findings that caught our attention.
In this week’s roundup: On the same day, the European Commission and FDA separately released important documents addressing fundamental medical device risk-classification processes; China continues its very active streak of policymaking as it continues to ramp up regulatory reform implementation; EUDAMED slowly expands; and more global medtech policy insights.
The program allowing device firms to contract with accredited bodies to review 510(k)s has yet to gain real momentum after 24 years. But FDA says its recent efforts to improve the quality of third-party reviews is having an impact and that the framework is an important underpinning of its global harmonization vision. The leading third-party review firm, meanwhile, acknowledges business is slow, but she is committed to expanding the program.