US FDA consulting for medical device and IVD manufacturers covers the regulatory work needed to bring a product to the US market and keep it there: device classification, pathway selection between 510(k), De Novo, and PMA, technical documentation, and alignment of the manufacturer's quality system with the FDA's Quality Management System Regulation (QMSR). For companies based outside the US, it also includes establishment registration and US Agent representation.

Why work with Qserve on your FDA strategy?

A pathway diagram only gets a manufacturer so far. A device clears FDA review when its classification, predicate strategy, and quality system evidence align end-to-end, not when a different vendor handles each. Qserve's US team has taken more than 100 devices through 510(k) clearance. It represents over 100 foreign manufacturers as their US Agent, so the strategy work is grounded in submissions that were actually reviewed.

• Deep FDA expertise across submissions, inspections, and post-market compliance

• Regulatory strategy built around your specific product and business objectives, not a template

• Integrated support across the US, EU, and international markets. One strategy, not three separate vendors

• A risk-based, practical approach focused on speed to submission without cutting corners.

When do you need FDA regulatory support?

Most manufacturers bring in FDA-specific expertise at one of a few recognizable points: before writing a regulatory strategy, when quality system gaps surface ahead of an inspection, or after FDA pushes back on a submission drafted without US regulatory input.

• Planning a first US launch and choosing between 510(k), De Novo, and PMA

• Transitioning a QSR-based quality system to the QMSR before an FDA inspection

• Preparing a Pre-Submission (Q-Sub) to test strategy with the FDA before filing

• Responding to a 483 observation, warning letter, or Additional Information request

• Registering as a foreign establishment and appointing a US Agent for the first time

Which FDA pathway fits your device? 510(k), De Novo, or PMA?

Most medical devices enter the US market through one of three FDA pathways: a 510(k) premarket notification demonstrating substantial equivalence to a cleared predicate device, a De Novo request for novel low- to moderate-risk devices with no predicate device, or a PMA for Class III devices requiring full scientific review.

Qserve prepares and reviews submissions across all three pathways and drafts them directly in the FDA's electronic template. FDA eSTAR Program review timelines vary by pathway: FDA's MDUFA performance goals target roughly 90 review days for a standard 510(k) and 180 days, or 320 with an advisory panel, for a PMA, though an Additional Information request pauses the clock until you respond. A Pre-Submission (Q-Sub) meeting before filing is the most reliable way to catch a wrong pathway choice before it costs a review cycle.

Qserve prepares and reviews submissions across the full range of FDA pathways:

• 510(k) Premarket Notifications

• De Novo requests

• PMA submissions

• Pre-Submissions (Q-Sub program)

• Investigational Device Exemptions (IDE)

• Breakthrough Device and Safer Technologies Program (STeP) applications

• CLIA Waivers, EUAs, HDEs, and PCCPs

  What does FDA QMSR compliance require now that the rule is in effect?

  The Quality Management System Regulation (QMSR) took full effect on 2 February 2026, replacing the FDA's Quality System Regulation (21 CFR Part 820) and incorporating ISO 13485:2016 by reference. The FDA has retired its QSIT inspection technique.

  For manufacturers already certified to ISO 13485, the gap is usually the FDA-specific requirements layered on top of the standard: complaint handling, MDR reporting, and design control documentation that ISO 13485 alone doesn't fully specify. Qserve runs QMSR gap assessments, MDSAP-aligned audits, and FDA mock inspections to close those gaps before an investigator finds them. 

  For a full walkthrough of how FDA inspections changed under the QMSR, see FDA Inspections 2026: The QMSR Reset and the New Era of Risk-Based Enforcement.

  How does US FDA consulting differ from EU MDR & IVDR consulting?

  US FDA consulting and EU MDR & IVDR Consulting solve the same problem, market access, through different systems: the FDA reviews device-specific pathways such as 510(k), De Novo, and PMA, while the EU requires Notified Body conformity assessment against MDR or IVDR with no predicate-based route. A manufacturer targeting both markets needs two distinct strategies, though clinical and performance evidence can often be shared in part.

• Deep FDA Expertise
  Extensive experience with FDA submissions and FDA interaction, inspections, and compliance
• Tailored Regulatory Solutions
  Strategies aligned with product, company, and business objectives
• Global Regulatory Perspective
  Integrated support across US, EU, and international markets
• Practical, Risk-Based Approach
  Focus on efficiency, speed, and sustainable compliance