FDA submissions for medical devices

FDA submission services

Gaining FDA approval or clearance is essential for medical device manufacturers looking to enter the US market. The submission process can be complex, with stringent requirements for clinical evidence, technical documentation, and risk management. Missteps can lead to costly delays or rejections.

Our consultants guide you through the FDA submission process, ensuring a smooth pathway to market entry while maintaining compliance with 21 CFR Part 820 and other regulatory requirements.

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Expert support for FDA submission success

The US Food and Drug Administration (FDA) has multiple regulatory pathways depending on a device’s risk classification and intended use. Choosing the right submission strategy and preparing high-quality documentation are critical to achieving a timely approval or clearance.

Our consultants help you:

  • Identify the appropriate submission pathway based on your device classification (e.g., 510(k), De Novo, PMA, or Exempt).
  • Assist with Pre-Submissions to interact and align with FDA early in the process.
  • Support with designation requests for Breakthrough Device Exemption (BDE), Humanitarian Device Exemption (HDE), etc.
  • Develop and compile high-quality technical documentation for 510(k), De-Novo and PMA Submissions
  • Guide you through clinical data requirements and performance testing to strengthen your submission.
  • Support interactions with FDA, including addressing deficiencies and responding to requests for additional information.

Why use our support for your FDA submission process?

Achieving FDA clearance or approval requires deep regulatory expertise, strategic planning, and precise execution. With our expert guidance, your company can confidently navigate FDA submissions, ensuring timely market entry and long-term regulatory compliance in the US.

Our services include:

  • Pre-Submission (Q-Sub) Requests and Meetings – Engaging with FDA early to gain feedback and clarify expectations.
  • 510(k) Submissions – Preparing substantial equivalence reports, risk assessments, and testing data for FDA clearance.
  • De Novo Applications – Supporting innovative device manufacturers in obtaining a new product classification.
  • Premarket Approval (PMA) Submissions – Assisting with clinical study design, evidence generation, and comprehensive regulatory documentation for high-risk devices.
  • Breakthrough Device, Humanitarian Device & Safer Technologies Program (STeP) Support – Guiding manufacturers of novel technologies through expedited approval pathways.
  • Labeling & UDI Compliance – Assisting with regulatory labeling, instructions for use, and Unique Device Identification (UDI) implementation.
  • FDA Inspection & Post-Market Compliance Support – Helping companies comply with Quality System Regulation (21 CFR Part 820) and post-market surveillance requirements.
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.