ABOUT

Stephen P. Rhodes, MS

Principal, Streamline Regulatory

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.

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:

  • 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)

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:

  • 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

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