# FDA WARNING_LETTER - Impladent Ltd. - October 03, 2013

Source: https://www.keypedia.com/records/warning_letter/impladent-ltd/56012b12-df99-403d-8e47-bb319c7e063e

> FDA WARNING_LETTER for Impladent Ltd. on October 03, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Impladent Ltd.
- Inspection Date: 2013-10-03
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/impladent-ltd/d8713d2d-2746-4f0a-b416-706524f61a7a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7