The US Food and Drug Administration (FDA) has issued a draft guidance for clinical investigations of prostate tissue ablation devices including focused ultrasound systems.
Specific recommendations for the collection of clinical data to support 510(k) and PMA submissions are included. Among these recommendations are:
- Clinical evidence from an internally- or externally-controlled trial (using comparator devices/procedures) with minimum of 100 patients
- Minimum duration of one year for follow-up – prostate biopsy, PSA levels, prostate volume; treat and resect data can be obtained less than one month post-ablation
Focused ultrasound companies with prostate ablation devices are encouraged to review this draft guidance and submit comments by August 26, 2019, under docket number FDA-2019-D-2223. Leadership of the MITA-FUSF partnership is also reviewing this guidance and consulting with our member companies to prepare comments on behalf of our focused ultrasound working group.