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U.S. FDA — CDRH

FDA Compliance U.S. Food & Drug Administration

The U.S. FDA regulates the safety and effectiveness of medical devices sold in the United States. FDA compliance ensures your device meets every regulatory requirement for legal marketing and distribution — one of the largest medical device markets in the world.

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Regulatory specialist signing FDA submission documents
Program
FDA
Authority
U.S. FDA — CDRH
Market
United States
Delivery
End-to-end RA support

What it is

What is FDA compliance?

FDA compliance means meeting the requirements set by the FDA’s Center for Devices and Radiological Health (CDRH). Depending on device classification (Class I, II or III), the FDA may require a premarket notification [510(k)], De Novo request or premarket approval (PMA), plus establishment registration, device listing, labeling and post-market surveillance.

  • Device classification and regulatory pathway determination
  • 510(k), De Novo or PMA submission where required
  • Quality Management System Regulation (QMSR, 21 CFR Part 820 — aligned with ISO 13485 since Feb 2026)
  • Unique Device Identification (UDI)
  • Establishment registration & device listing

Why it matters

Why FDA compliance is critical

  • Access to one of the world’s largest medical device markets
  • Assured safety and effectiveness of your products
  • Reduced risk of warning letters, import alerts and recalls
  • Credibility and trust with healthcare providers and patients

How we help

Our FDA services

  • Device classification & regulatory pathway analysis
  • 510(k) and De Novo preparation and submission
  • QMS implementation aligned with QMSR / 21 CFR Part 820 and ISO 13485
  • UDI compliance and labeling support
  • Establishment registration & device listing
  • Post-market surveillance, complaint handling and MDR (Medical Device Reporting) setup

01

Regulatory expertise

Deep knowledge of FDA device rules, guidance documents and submission processes.

02

Fast turnaround

Registration and listing work completed quickly, with submission timelines agreed up front.

03

Complete guidance

From premarket strategy to full post-market compliance.

04

Document accuracy

FDA-ready submissions built to minimize additional-information requests.

The regulatory journey

From regulatory strategy to FDA approval

  1. 01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
  2. 02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
  3. 03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
  4. 04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
  5. 05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
  6. 06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.

FAQ

FDA frequently asked questions

01What is 510(k) clearance?

A 510(k) is a premarket submission demonstrating that your device is substantially equivalent to a legally marketed predicate device.

02Is FDA registration the same as FDA approval?

No. Establishment registration and device listing are mandatory for most manufacturers, but they do not mean the FDA has cleared or approved the device.

03Do all devices need a 510(k) or PMA?

No. It depends on classification. Many Class I and some Class II devices are exempt from premarket notification; most Class III devices need PMA.

04What is the QMSR?

The Quality Management System Regulation replaced the former Quality System Regulation on 2 February 2026. It amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, alongside FDA-specific requirements.

05How long does FDA clearance take?

The FDA’s review goal for a 510(k) is 90 FDA days, though total time is often longer once information requests are included. PMA review typically takes considerably longer depending on device complexity.

Free consultation

Request a FDA consultation.

Share a few details and one of our lead auditors will respond within 24 hours with recommended next steps and a fixed-price proposal.

We respond within one business day. Your information is kept strictly confidential.

Related services

ISO 13485

Medical Devices Quality Management System

The quality management foundation for FDA, EU MDR and MDSAP compliance.

MDSAP

MDSAP Compliance

One regulatory audit accepted by five major markets.

cGMP

Current Good Manufacturing Practice

FDA-aligned manufacturing controls for pharmaceutical and biotechnology companies.