top of page
Vials

FDA Regulatory and Compliance Support Services

At Verus, we understand that navigating FDA regulations is critical for the successful development, approval, and commercialization of medical, biotech, pharmaceutical, and food-related innovations. Our multidisciplinary team combines intellectual property expertise with regulatory knowledge to guide clients through the complex FDA landscape efficiently and confidently.

FDA Submission & Correspondence

  • Preparation and Submission of 510(k) Premarket Notifications

  • Strategic Planning and Facilitation of FDA Pre-Submission (Q-Sub) Meetings

  • Breakthrough Device Designation Applications and Support

  • Investigational Device Exemption (IDE) Preparation and Regulatory Strategy

  • De Novo Classification Requests for Novel Devices

  • Requests for FDA Enforcement Discretion Determinations

  • 513(g) Requests for Classification and Regulatory Guidance

  • Designated FDA U.S. Agent and Official Correspondent Services

  • Labeling & Disclaimers 

  • Amazon Compliance 

Regulatory & Development

  • Medical Devices & Digital Health Technologies

  • Wearables & Remote Patient Monitoring Systems

  • AI-Driven Imaging and Next-Generation Diagnostic Platforms

  • Antimicrobial Technologies & Infection Control Claims

  • Neonatology & Perinatal Health Solutions

  • Women’s Health, Urology & Reproductive Care

  • Pulmonary & Respiratory Therapeutics and Devices

  • Metabolic & Endocrine Health Management Tools

  • Neurology, Cognitive & Mental Health Innovations

  • Rehabilitation Technologies & Assistive Medical Devices

  • Orthopedic Solutions & Implantable Medical Devices

  • Cardiovascular Devices & Advanced Imaging Systems

Joint Pain

Industries We Serve 

  • Cosmetics ​

  • Dietary Supplements 

  • Sports Equipment

  • Medical Devices

  • Sport Drinks 

  • Recovery Equipment 

bottom of page