Impladent Ltd. – FDA Warning Letter, Oct 3, 2013

The FDA issued a Warning Letter to Impladent, Ltd. following an inspection from September 12 to October 3, 2013, prompted by a Premarket Notification (510(k)) submission. The inspection aimed to assess compliance with federal regulations for the clinical study "(b)(4)" involving a combination product, (b)(4), comprised of a device ((b)(4) material) and a drug ((b)(4)).

The inspection revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to obtain FDA and IRB approval:** Impladent, Ltd. enrolled at least (b)(4) subjects in the study, administering the investigational (b)(4), a significant risk device, without submitting an IDE application or obtaining prior IRB and FDA approval. The firm's response stating study termination lacked supporting documentation. 2. **Inadequate informed consent:** Consent documents were not IRB-approved, failed to disclose advantageous alternative treatments (e.g., (b)(4), (b)(4), (b)(4), and (b)(4)), and contained impermissible exculpatory language releasing the sponsor from liability for injury. 3. **Failure to obtain investigator agreements and maintain product disposition records:** The firm shipped (b)(4) to (b