ARTICLE SUMMARY:
EU lays out clinical shortcuts for orphan devices and explores brain stim risks; Edwards seeks tricuspid valve coverage via FDA-CMS Parallel Review; FDA publishes guides on diversity action plans, lab tests, and denying inspection access; IMDRF updates submission templates; and regulatory and reimbursement updates from Australia, France, Canada, Taiwan, and Saudi Arabia.
EU Picks
Orphan device path, brain stim review, and HTAs:
Streamlined orphan device route. Medical devices targeting conditions with unmet needs impacting 12,000 individuals or less in the EU annually can be certified under the Medical Device Regulation with abridged premarket clinical data under a guidance published June 25. The new policy follows years of calls by industry and EU member state officials for a special MDR orphan device pathway. The guide says notified bodies can accept a “limited level of pre-market clinical data” if all available (clinical and non-clinical) data has been evaluated and it is sufficient to demonstrate that relevant “general safety and performance requirements” are met. Manufacturers also must show the device is expected to provide a clinical benefit with an acceptable benefit-risk ratio and that it is not feasible or proportionate to generate more clinical data in a reasonable time frame. Instead, the manufacturer must have an adequate post-market follow-up plan in place and clearly inform device users of the orphan status of the device. The guidance cites the EU’s “Charter of Fundamental Rights (health care)” to legally support the adjusted clinical standards for orphan devices, but stakeholders worry the updates will not be robust until they are embedded in an official legislative amendment to the MDR.“The procedural part of the guidance ... is wafer thin and does not contain any hard commitment regarding duration of procedure,” Netherlands-based device attorney Erik Vollebregt noted. The orphan pathway doesn’t apply to IVDs as it currently stands.
