Food & Drug Administration (FDA) Compliance Services
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices sold in the United States. FDA compliance ensures your device meets all regulatory standards for legal marketing and distribution in the U.S.
What is FDA Compliance?
FDA compliance refers to fulfilling the regulatory requirements set by the FDA’s Center for Devices and Radiological Health (CDRH). Depending on the classification of your medical device (Class I, II, or III), FDA mandates premarket notification [510(k)], premarket approval (PMA), establishment registration, device listing, labeling, and post-market surveillance.
Key FDA compliance elements include:
- Device classification and regulatory pathway determination
- Submission of 510(k) or PMA (if required)
- Quality System Regulation (QSR) compliance (21 CFR Part 820)
- Unique Device Identification (UDI)
- Establishment Registration & Device Listing
Why is FDA Compliance Important?
FDA compliance is essential for selling medical devices in the U.S. It:
- Grants access to one of the world’s largest medical device markets
- Ensures safety and effectiveness of products
- Reduces risks of enforcement actions like warning letters or product recalls
- Enhances brand credibility and trust with healthcare providers and patients
Our FDA Compliance Services
Lisora provides expert guidance and hands-on support to help you meet FDA regulatory requirements. Our services include:
- Device classification & regulatory pathway analysis
- 510(k) preparation and submission
- QMS implementation aligned with 21 CFR Part 820
- UDI compliance and labeling support
- Establishment Registration & Device Listing assistance
- Post-market surveillance setup and compliance
Why Choose Lisora for FDA Compliance?
Regulatory Expertise
Deep knowledge of FDA device regulations and submission processes
Fast Turnaround
Complete all submissions in under Five working days
Complete Guidance
From premarket strategy to post-market compliance
Document Accuracy
FDA-ready submissions with minimal delays
Frequently Asked Questions (FAQs)
1. What is 510(k) clearance?
510(k) is a premarket submission to the FDA demonstrating that your device is substantially equivalent to a legally marketed device.
2. Is FDA registration the same as approval?
No. Establishment registration and device listing are mandatory for most manufacturers, but they do not imply FDA approval.
3. Do all devices require a 510(k) or PMA?
Not all devices need a 510(k) or PMA. It depends on the device classification. Class I devices often do not require premarket submissions.
4. What is QSR (21 CFR Part 820)?
Quality System Regulation outlines the good manufacturing practices (GMP) required for medical device production in the U.S.
5. How long does FDA approval take?
It varies: 510(k) review typically takes 90 days, while PMA can take several months or longer depending on device complexity.
