Comprehensive FDA Compliance Services
- 510(k) Filing (Traditional, Special, Abbreviated)
- De Novo Classification Support
- PMA Submission & Approval
- US Agent Services for FDA-registered establishments
- Quality System Compliance (21 CFR Part 820)
- UDI Labeling Compliance
- MDSAP Certification Support
- QSR compliance for Combination Products (21 CFR Part 4)
- BIMO Audit Compliance
- Pre-Market Notification / 510(k) Clearance (Traditional, Special, Abbreviated)
- De-Novo Classification
- Pre-Market Approval (PMA) – Original and Supplements
- Humanitarian Device Exemption (HDE)
- Investigational Device Exemption (IDE)
- Pre-RFD and RFD Submission to Office of Combination Products)
- Q-Submission Meetings with US FDA (Pre-Submission, SIR, Study Risk Determination)
- 21 CFR 801 – General Labeling Compliance and Device-Specific Compliance
- UDI Labeling Compliance
- Small Business Designation (SBD) and CLIA Waiver
Ready to Navigate Complex and FDA medical device product registration with ease?
Success Stories
Freyr Solutions helped a UK-based company overcome Regulatory hurdles by filling in missing data and clarifying predicates for fast-track 510(k) approval, ensuring complete FDA company registration and compliance.
Frequently Asked Questions
A 510(k) is required for devices with a legally marketed predicate. This process demonstrates that your device is as safe and effective as an existing FDA-registered medical device on the market.
- 510(k): For devices similar to existing ones on the market (moderate risk).
- De Novo: For novel devices without a predicate (moderate to low risk).
- PMA: Required for high-risk devices where extensive safety and efficacy data is necessary.
The duration varies depending on the pathway chosen. A 510(k) submission typically takes 90-120 days, while a PMA process can take 180 days or longer. Freyr Solutions ensures a faster and more efficient process through meticulous preparation and support for FDA establishment registration.
You'll need details such as:
- Device classification and intended use
- Design, performance, and safety data
- Clinical evidence (if applicable)
- Labeling and packaging information
Freyr assists in seamlessly compiling and managing these elements to ensure you're a fully FDA-registered manufacturer.
The FDA requires foreign manufacturers to appoint a US Agent to manage communication and ensure Regulatory compliance. Freyr's proven expertise as a trusted US FDA-registered establishment agent simplifies your engagement with the FDA.
Absolutely. Freyr provides complete post-market surveillance, labeling updates, audit readiness support, and compliance monitoring for FDA-registered sites.
Freyr accelerates approvals by:
- Identifying the correct submission pathway
- Conducting a detailed gap analysis of technical documents
- Providing pre-submission strategies and Regulatory meetings with the FDA
