# FDA WARNING_LETTER - Malcolm, Matthew PhD., OTR - February 16, 2012

Source: https://www.keypedia.com/records/warning_letter/malcolm-matthew-phd-otr/727d266c-4068-4acc-87e7-84c521c77d9e

> FDA WARNING_LETTER for Malcolm, Matthew PhD., OTR on February 16, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Malcolm, Matthew PhD., OTR
- Inspection Date: 2012-02-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On May 22, 2012, the FDA issued a Warning Letter to Dr. Matthew P. Malcolm, Sponsor-Investigator of the "Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct to Constraint-Induced Therapy" clinical study (IDE (b)(4)) at Colorado State University. This followed an inspection from February 10-16, 2012, which identified violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects).

Key violations include:
1.  **Failure to ensure informed consent (21 CFR 50.25(a)(2) and 812.100):** All subjects signed an Informed Consent Document (ICD) that lacked FDA-required and IRB-approved information on risks (permanent hearing loss) and exclusion criteria (large-stroke lesions). The response was inadequate, lacking a procedure for ensuring correct ICD use and staff training.
2.  **Failure to maintain accurate adverse event records (21 CFR 812.140(a)(3)(ii)):** Seven reported changes in subjects' health (e.g., partial arm function loss, headache, cut requiring hospital visit, blistering, thyroid cyst, low blood pressure, rash/illness) were not documented as reviewed by the investigator or reported to the IRB, DS

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Matthew P. Malcolm](https://www.keypedia.com/people/matthew-p-malcolm/7fc24e0b-5ee0-4b80-b48f-72a9b28e3b0d)

Company: https://www.keypedia.com/companies/malcolm-matthew-phd-otr/4291a37f-3fd9-4e9e-8b2e-2ec94d9b520d

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