US Medical Devices Regulatory Services

Navigating the complex regulatory landscape of the U.S. medical device industry requires deep expertise, meticulous documentation, and a well-defined strategy. At iMDR MedTech, we specialize in comprehensive regulatory consulting for medical devices, ensuring smooth FDA approvals, compliance with 21 CFR Part 820 (QSR), ISO 13485, and successful market entry.

With a team of 200+ global regulatory experts, we help medical device manufacturers, importers, and distributors streamline regulatory submissions, optimize compliance processes, and avoid costly delays.

Understanding the US FDA Regulatory Framework for Medical Devices

The U.S. Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Compliance with FDA regulations is mandatory for manufacturers looking to sell medical devices in the U.S. market.

Key FDA Regulatory Requirements for Medical Devices

• Medical Device Classification (Class I, II, III)

• 510(k) Premarket Notification (PMN)

• Premarket Approval (PMA) for High-Risk Devices

• De Novo Classification for Innovative Devices

• Investigational Device Exemption (IDE) for Clinical Trials

• FDA Establishment Registration & Device Listing

• Quality System Regulation (QSR) – 21 CFR Part 820

• Unique Device Identification (UDI) Compliance

• Medical Device Reporting (MDR) & Post-Market Surveillance

• FDA Inspections & Audits

Our team at iMDR MedTech provides end-to-end regulatory support, helping you navigate each step efficiently.

Our Comprehensive US Medical Devices Regulatory Services

✅ Medical Device Classification & Regulatory Strategy Development

Determining the correct FDA classification is crucial to selecting the right regulatory pathway. Our experts:

• Identify the appropriate device classification (Class I, II, III) under FDA 21 CFR Part 860.

• Conduct regulatory gap analysis and assess compliance requirements.

• Develop a strategic regulatory roadmap to ensure smooth FDA submission.

• Guide manufacturers through predicate device analysis for 510(k) clearance.

✅ 510(k) Premarket Notification – FDA Clearance Support

A 510(k) submission is required for Class II medical devices unless exempt. Our team:

• Prepares a comprehensive 510(k) submission package, including:

  • Device description and intended use.

  • Substantial Equivalence (SE) comparison with a predicate device.

  • Biocompatibility, sterilization, and performance testing data.

  • Software and cybersecurity documentation (for digital devices).

  • FDA guidance adherence, including ISO 10993, IEC 62366, and IEC 62304.

• Responds to FDA Additional Information (AI) requests to avoid submission delays.

• Helps you navigate Special 510(k) and Abbreviated 510(k) pathways.

✅ Premarket Approval (PMA) – High-Risk Devices

Class III devices require a rigorous Premarket Approval (PMA) application. We support:

• Clinical trial design and Investigational Device Exemption (IDE) filings.

• Preparation of comprehensive scientific and clinical data for FDA review.

• Development of Regulatory Affairs Strategy for PMA approval.

✅ De Novo Classification – For Innovative Medical Devices

For devices with no predicate (novel technology), our De Novo submission support includes:

• Risk-based classification and assessment.

• Development of non-clinical and clinical validation strategies.

• Full support from pre-submission (Q-Sub) to De Novo decision approval.

✅ FDA Investigational Device Exemption (IDE) & Clinical Trial Support

For devices requiring clinical testing, we assist with:

• IDE application and FDA pre-approval process.

• Study design optimization and protocol development.

• Compliance with Good Clinical Practices (GCP) and ISO 14155.

• Data collection and reporting for PMA and De Novo applications.

✅ Quality System Regulation (QSR) – 21 CFR Part 820 Compliance

All U.S. medical device manufacturers must comply with FDA’s QSR requirements, covering:

• Design Controls & Design History File (DHF).

• Process Validation (IQ, OQ, PQ) & Manufacturing Controls.

• Supplier Quality Management & Vendor Audits.

• Corrective & Preventive Actions (CAPA) and Nonconformance Reporting.

✅ FDA Establishment Registration & Device Listing

We assist medical device manufacturers, importers, and foreign companies in:

• Completing the FDA Establishment Registration process.

• Ensuring accurate Device Listing and compliance verification.

✅ Labeling, Unique Device Identification (UDI) & Marketing Compliance

• Ensuring FDA-compliant labeling, Instructions for Use (IFU), and marketing claims.

• Assisting with UDI implementation per FDA GUDID requirements.

✅ FDA Inspections, Compliance Audits & 483/Warning Letter Responses

• Preparing manufacturers for FDA inspections and audits.

• Addressing FDA Form 483 observations and Warning Letters.

• Conducting mock audits to ensure FDA compliance readiness.

✅ Post-Market Surveillance, MDR & Recall Management

• Developing FDA-compliant Medical Device Reporting (MDR) procedures.

• Assisting in risk assessment and recall execution.

• Supporting Periodic Safety Update Reports (PSUR) and Field Safety Corrective Actions (FSCA).

Why Choose iMDR MedTech for FDA Regulatory Services?

✔ 200+ Global Experts – A team of experienced regulatory consultants, auditors, and engineers.
✔ Regulatory Excellence – Deep expertise in FDA QSR, ISO 13485, and international compliance.
✔ Accelerated Market Access – Optimized 510(k), PMA, and De Novo pathways to reduce time to market.
✔ Tailored Solutions – Custom strategies for startups, SMEs, and multinational manufacturers.
✔ Global Reach – We support companies worldwide in achieving FDA and international regulatory compliance.

Get Your Medical Device FDA-Ready with iMDR MedTech

With iMDR MedTech, you gain a trusted regulatory partner dedicated to simplifying FDA compliance and fast-tracking approvals. Whether you need support with 510(k) submissions, PMA applications, QMS implementation, or FDA audits, we’re here to help!

📩 Contact us today at info@imdrmedtech.com for expert guidance on US Medical Devices Regulatory Services!