Expertise.
FDA approval of medical devices.
Compliant with the rules?
Future-proof?
Efficient?
Your successful market access in the USA.
Companies in the medical technology and in-vitro diagnostics (IVD) sectors face the challenge of meeting the complex FDA requirements. A well-founded regulatory strategy approach is essential in order to make the approval process efficient and legally compliant. We support you in selecting the appropriate approval procedure - whether Premarket Notification (510(k)), De Novo or Premarket Approval (PMA) - and guide you through the entire process: from classification and technical documentation to successful submission.
Our services include analyzing your product to select the appropriate approval process, preparing and reviewing technical documentation including clinical studies, formal submission to the FDA and communication with the agency. In addition, we offer comprehensive post-approval management, including post-market surveillance (PMS) and ongoing documentation maintenance to ensure long-term compliance.
Reach the US market faster with our FDA approval expertise.
FDA approval of medical devices - a safe way into the US market.
Product classification and process selection.
- Check whether the product already has a corresponding Predicate Device (for 510(k))
- Assessment of whether a de novo classification makes sense
- Assessment of whether a PMA application is necessary (e.g. for high-risk products)
Technical documentation and clinical evidence.
- Creation of product master files and device descriptions
- Compilation of clinical data and literature for proof of safety and efficacy
- Risk management in accordance with internationally recognized standards (e.g. ISO 14971)
Submission and communication with the FDA.
- Preparation of the submission package according to FDA format
- Reply to Request for Additional Information (AI-Letter)
- Coordination of any additional requirements (e.g. additional studies)
Case Studies - Successful FDA approvals for medical devices.
Challenge.
A European manufacturer wanted to launch its surgical instrument in the USA as quickly as possible and had to provide evidence of a predicate device.
Measures.
- Selection of a suitable comparator product (predicate device) to ensure substantial equivalence.
- Preparation of technical documentation in accordance with the requirements for 510(k) submission.
- Coordination with external laboratories to carry out the necessary tests and prepare the test reports.
- Planning the submission strategy and defining milestones.
Effort.
- Rapid recognition of substantial equivalence by the FDA.
- Minimization of time expenditure through careful planning and targeted selection of the comparison product.
Success.
Rapid market entry and sustainable expansion of market share in the USA.
Reach the US market safely.
Our service for FDA approval of medical devices.
We support you in selecting the appropriate approval procedure - Premarket Notification (510(k)), De Novo or Premarket Approval (PMA) - and prepare complete technical documentation in accordance with FDA requirements for premarket submissions.
For medical devices with software functions, we create the necessary documentation in accordance with the FDA guidelines for software functions. We also integrate cybersecurity aspects in accordance with the FDA recommendations on cybersecurity.
We take care of the formal submission of your documents via the CDRH portal, coordinate communication with the FDA and provide support in answering queries.
After approval, we support you in implementing post-market surveillance (PMS) activities, including monitoring device performance and reporting adverse events. In the event of product changes, we assess the need for new approvals and update the documentation accordingly.
