Stephen P. Rhodes, MS

Principal, Streamline Regulatory

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Mr. Rhodes has 29 years of experience in the regulation of medical devices and combination products. Prior to starting Streamline Regulatory in 2018, Mr. Rhodes worked as a Senior Consultant at Biologics Consulting Group for 8 years.

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Before joining BCG, Mr. Rhodes worked for more than 20 years at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation:

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• Director, Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) Programs (2007–2010)

• Acting Deputy Division Director, Division of General, Restorative, and Neurological Devices (2005)

• Acting Deputy Division Director, Division of General, Restorative, and Neurological Devices (2002)

• Acting Deputy Division Director, Division of Cardiovascular and Respiratory Devices (2001)

• Branch Chief, Plastic and Reconstructive Surgery Devices Branch (1996–2007)

• Team Leader, Orthopedic Devices Branch (1995)

• Engineering Reviewer, Orthopedic Devices Branch (1989–1996)

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Mr. Rhodes managed the engineering, medical, and clinical review of the data and subsequent approval of many first-of-a-kind medical devices that have had a significant impact on public health, including:

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• the first approved saline-filled and silicone gel-filled breast implants

• the first cyanoacrylate tissue adhesive

• the first cyanoacrylate neuroembolization device

• the first dural sealant

• the first neurological stent for aneurysms

• the first sealant for pulmonary surgery

• the first sealant for cranial surgery

• the first hyaluronic acid dermal filler

• the first dermal filler for lipoatrophy in patients with HIV

• the first non-viable human cellular product, for burn patients

• the first viable human cellular product, for chronic ulcers