Our Services BASED ON New LDT Rule Phaseout Policy

• Audit and gap assessment of operations for QSR compliance 
• Assistance with QSR compliance (Reporting, Records compliance)
• Portfolio Review for business considerations and prioritization of products for compliance 
• Risk Classification for Priority Products and assignment of FDA Product codes in preparation for Establishment Registration and Device Listing for Phase 2
• Prepare, submit and lead Pre-submissions and meetings with FDA, where needed, to gain agreement on device classification, in preparation for Device Listing, IDE and /or PMA and 510(k) submissions.

• Perform Establishment and Registration Listing 
• Assist with IVD Labeling Requirements and review and approval of labeling
• Prepare and submit Investigational Device Exemption for LDTs to be used investigationally (prior to PMA approval or 510(k) clearance – i.e., to collect clinical data in support of future submission)

• Assist with requirements for developing and provide support for implementing system of Design Controls, Purchasing and Supplier controls, Established Acceptance activities and CAPA.
• Assist with Records requirements (Part 11, retention policies) 

• Prepare and manage Premarket submissions for High Risk LDTs and down classification evaluation.
• Prepare, manage and lead Pre-submissions for FDA feedback on appropriate classification, where needed.

• Prepare and manage Premarket submissions for Medium Risk LDTs 
• Prepare, manage and lead Pre-submissions for FDA feedback on submission requirements, where needed
• Evaluate Low Risk IVDs for exemption from Premarket approval and document rationales.

We can provide support through your post-compliance phase and perform audits, as needed