The Medical Devices Introductory Course 2020

Development & Testing

Clinical Investigations

• Required for PMA applications and some 510(k), de novo and HDE filings • Conducted under “ Investigational Device Exemption ” (IDE) – Abbreviated requirements for “ Non-Significant Risk Devices ” (IRB plus labelling) – Full IDE for “ Significant Risk Devices ” requires IDE filing and approval by FDA – IRB(s) may decide “Significant Risk” status (FDA decision binding if IRB undecided or conflicting) • IDE Filing: – Key content: all relevant technical, non-clinical and clinical data, protocol – 30 day review cycle – No fee • List on www.clinicaltrials.gov • Foreign clinical studies / data may be accepted by FDA if the study conducted to GCP and study data, subject population and medical practice is relevant to the US

Submit to FDA CDRH (or CBER)

FDA Clearance or Approval

Submission format, content and review timeframe vary by type of submission:

• 510(k) application and clearance: – 90 day review cycle / 3-9m – $12K fee • PMA application and approval: – 180 day review cycle / 6-18m – $341K fee

• De novo reclassification order and decision: – No fixed review cycle time / 1-15m – $102K fee

• HDE (and HUD) application and approval: – 30 day initial review, with 75 day substantive review cycle

• Submit all applications to CDRH, except for devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products, which should be submitted to CBER. CBER also regulates all HIV test kits.