Market Growth
During the market growth stage, focus shifts to scaling production, expanding market access, and optimizing postmarket surveillance to support broader adoption while maintaining regulatory compliance.
Regulatory Assessment for Device Modifications
Changes are an expected part of the combination product lifecycle, whether related to design, manufacturing, labeling, or indication. It’s essential to perform a thorough regulatory assessment for each change to ensure continued compliance with applicable requirements and to determine whether regulatory notifications, submissions, or revalidations are needed. Covita Health Partners can help you assess, document, and implement changes with confidence to minimize risk and ensure uninterrupted market access.
510(k) for Device Modifications
If a regulatory assessment determines that a new 510(k) submission is required for a device-led combination product, Covita Health Partners can guide you through every step of the process, from defining the regulatory strategy and gathering necessary data to authoring the submission and engaging with the FDA. Our expertise ensures your filing is thorough, timely, and aligned with current expectations, helping you avoid delays and maintain market momentum.
PMA Supplements and Amendments
PMA-approved device-led combination products require ongoing regulatory maintenance, including the submission of PMA supplements, amendments, and annual reports. Our team can help you develop a strategic approach to managing these obligations, ensuring timely, accurate submissions while reducing the burden on your internal team. Our support helps you stay compliant, minimize risk, and keep your product on the market without disruption.
Technical File/Design Dossier Updates
Maintaining an up-to-date technical file or design dossier is essential for ongoing compliance with device-led combination product regulatory requirements. These documents must be regularly reviewed and updated to reflect product changes, postmarket data, and evolving regulatory expectations. Covita Health Partners provides expert support in maintaining and updating your technical documentation, ensuring it remains audit-ready and aligned with current global standards.
Device Registration Amendments
Throughout the product lifecycle, amendments to device-led combination product registrations may be required in various countries outside the U.S. (OUS) due to changes in design, labeling, manufacturing, or regulatory status. Covita Health Partners can support the preparation and submission of these amendments, ensuring they meet local regulatory requirements and are submitted efficiently to minimize disruption to market access. Our global regulatory expertise helps you stay compliant and agile in an evolving international landscape.
Ad Promo/Labeling Review and Support
Our team can review advertising material and labeling to ensure the claims being made do not go outside of the authorized label. We can also help you implement an internal process to ensure the appropriate stakeholders are involved in the review and approval process to help prevent regulatory enforcement.
Health Hazard Evaluation
If a Health Hazard Evaluation (HHE) is required, we can provide comprehensive support throughout the entire process from data collection and risk assessment to health authority reporting. Should the evaluation conclude that a recall or other corrective action is necessary, we will guide you through the planning and execution to ensure regulatory compliance, protect patient safety, and minimize business impact.
Regulatory Compliance Support
Internal and external audits are nearly an everyday part of the postmarket phase. Learn more about our Regulatory Compliance capabilities and how we can support you stay prepared and operate with confidence.