Neural Noise

AdvaMed Medical Device Submissions Series: Investigational Device Exemption (IDE) Workshop

2 min read

  • AdvaMed runs a Medical Device Submissions Series including an Investigational Device Exemption (IDE) Workshop for teams preparing or running FDA IDE submissions.1
  • The workshop is directly actionable for BCI and neurotech device trials in the US (0–12 month regulatory execution).1 1

Weekly enrichment (2026-07-20)

  • AdvaMed’s Investigational Device Exemption (IDE) Workshop is part of its Medical Device Submissions Series and teaches regulatory, clinical and product teams the FDA IDE pathway from preclinical preparation through study approval.2
  • The 2026 session ran as a full-day virtual workshop on February 25, 2026, within the broader Medical Device Submissions Workshop Series held February 23-27 in Washington, D.C.23
  • The IDE Workshop is RAPS-accredited for up to 6 RAC recertification credits; the companion 510(k)/De Novo and PMA workshops carry up to 12 RAC credits each.3
  • The agenda covers “What Is an IDE?” (FDA speaker Anne Talley), developing an IDE strategy, preparing the technical/functional elements of an IDE, regulatory compliance during study conduct, reporting results, optimizing the pre-submission meeting, and BIMO inspections (FDA speaker Amrin Chowdhury).4
  • Sessions are led by FDA staff and industry regulatory experts (e.g., AtriCure, Hogan Lovells), using case studies to address common deficiencies, the role of risk analysis, and managing planned or unplanned device/study changes.4
  • Content includes using foreign data in a US submission, registering trials on ClinicalTrials.gov, interim and final clinical study reports, and incorporating results into premarket submissions.4
  • Implication for BCI/neurotech: the workshop is directly actionable for teams preparing FDA IDE submissions for implantable and stimulation/neuromodulation devices, with practical guidance on pre-submission engagement and BIMO inspection readiness.2

Footnotes

  1. https://news.google.com/rss/articles/CBMisAFBVV95cUxOV09oT3NMRjFtUGo0SFhzb200T0p2V0ExUk54bU5pSmI2Vnhmbk8xOVBCMVpoWTNiYXZkWUFJaHM1NEFYMWxxOUNOWGdMQWtFZEphS20xZGtEaTJUTk5IWXdkdndiRDM0OTNfaTVLckNwRUZ0bmV3bEtUOWpTU0l5MUlKTU5KMzdJREpkNlBuNXpnQk5fLXc4YTgyTm0yV01uZlpycGlfYTJ6SWRpMHFDRg?oc=5 ↩ ↩2 ↩3

  2. https://www.advamed.org/events/medical-device-submissions-workshop-series-investigational-device-exemption-ide/ ↩ ↩2 ↩3

  3. https://www.advamed.org/industry-updates/news/advamed-receives-raps-accreditation-for-medical-device-submissions-workshop-series-february-2026-in-washington-d-c/ ↩ ↩2

  4. https://www.advamed.org/wp-content/uploads/2025/12/2026-IDE-Submissions-Clean-Agenda.pdf ↩ ↩2 ↩3

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