mdi Consultants, IncShort answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.
July is an ideal time for a mid-year compliance review. With the QMSR now in effect and FDA inspections being conducted under the new framework, companies should use this opportunity to identify and address any compliance gaps before Q3.
1. Is your FDA establishment registration current?
FDA establishment registration is not a one-time requirement. It must be renewed annually, with the renewal period opening on October 1 and closing on December 31. Failure to renew can result in disruptions to the legal distribution of your devices in the United States.
Rather than waiting until the renewal period begins, companies should verify their registration status now. Confirm that the registration is active, company information and responsible officials are up to date, and funds have been allocated for the FY2026 FDA registration fee of $11,423. The fees are active till September 30, 2026 and will change from October 1, 2026. Taking these steps in advance helps ensure a smooth renewal process and avoids last-minute compliance issues.
2. Does your quality system actually reflect the QMSR?
The FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026, aligning FDA quality system requirements more closely with ISO 13485:2016. One of the most common mistakes companies make is assuming that compliance simply requires replacing old QSR references with ISO clause numbers. It does not.
The QMSR incorporates risk-based thinking throughout the quality system while retaining certain FDA-specific requirements. As a result, a quality system that has only been updated cosmetically may still fall short of compliance.
In addition, the FDA replaced its longstanding QSIT inspection approach with a new inspection program (CP 7382.850), changing not only the terminology but also the inspection framework itself. If your Quality Manual and SOPs have not been reviewed and updated since the QMSR became effective, now is the time to do so.
3. Are you ready for your next FDA inspection?
Inspection readiness is often where companies discover compliance gaps too late. The FDA is conducting inspections under the QMSR framework at both domestic and foreign facilities, making preparation more important than ever.
Before Q3, verify that your quality records, training documentation, CAPAs, and other inspection-related records are complete and readily available. If you have received FDA 483 observations, ensure that corrective actions have been implemented, documented, and remain on schedule. Unresolved observations carried into a follow-up inspection can significantly increase regulatory risk.
4. If you manufacture outside the US, is a US Agent on file?
All foreign establishments registered with the FDA must designate a U.S. Agent. Failure to maintain a current U.S. Agent can lead to regulatory issues, including delays in FDA communications and potential import complications.
Mid-year is a good time to verify that your U.S. Agent information is accurate and up to date. If you are preparing to enter the U.S. market, appointing a qualified U.S. Agent should be a priority before your products are shipped.
5. Should you reassess your market and reimbursement pathway?
Companies planning FDA submissions in the second half of the year should confirm their regulatory pathway, timelines, and budget now. Early planning helps identify testing requirements, submission milestones, and potential regulatory challenges before they impact project schedules.
If a 510(k), De Novo, or PMA submission is anticipated in Q3 or Q4, now is the time to evaluate your strategy and ensure the necessary resources are in place for a successful submission.
Why this checklist is worth taking seriously
Each of these compliance items is manageable on its own. The challenge is that many companies address them only when the annual registration renewal period begins, creating unnecessary pressure and increasing the risk of compliance gaps. A mid-year review helps identify and resolve issues before they become urgent.
Since 1978, MDI Consultants has helped medical device manufacturers navigate FDA regulations, quality system requirements, inspections, and market access challenges.
mdi Consultants experience includes:
- 4500+ FDA 510(k) submissions
- 1000+ companies served
- 1500+ products CE marked
- 50+ active retainer clients
- Fixed-price engagements with no hourly billing
By addressing compliance requirements proactively, companies can reduce risk, improve inspection readiness, and enter Q4 with confidence.
How mdi Consultants Can Help
Since 1978, MDI Consultants has assisted medical device manufacturers worldwide with FDA regulatory compliance, quality system implementation, and inspection preparedness. Whether you are a U.S. manufacturer or a foreign company entering the U.S. market, our team can help ensure that these critical compliance areas are addressed before they become costly problems.
Our services include:
- FDA Establishment Registration and Device Listing – Assistance with new registrations, annual renewals, device listings, and maintaining accurate FDA records.
- QMSR Compliance and Quality System Reviews – Gap assessments, Quality Manual and SOP reviews, QMSR implementation support, and alignment with FDA and ISO 13485 requirements.
- FDA Inspection Readiness – Mock inspections, internal audits, personnel training, and preparation for FDA inspections under the new QMSR framework.
- U.S. Agent Services – Designation and ongoing support as your FDA U.S. Agent, including communications with the FDA and assistance with regulatory inquiries.
- FDA 483 and Compliance Support – Review of FDA observations, development of corrective action plans, response preparation, and verification of implementation activities.
A mid-year compliance review can help identify potential gaps before they impact inspections, registrations, submissions, or market access. MDI’s experienced regulatory team can evaluate your current compliance status and provide practical recommendations to help keep your organization inspection-ready and compliant throughout the year.
Run your mid-year check with a senior advisor
MDI offers a free 30-minute compliance gap consultation — no obligation. It is a direct conversation with a senior regulatory advisor about where your devices stand against the five items above, and what to prioritize before Q3.
To make the call useful, have three things ready: your device class, your target market, and your current compliance status. From there, the advisor can tell you what needs attention now and what can wait.
Book your free consultation at mdiconsultants.com or call 516-482-9001 — we respond the same bnusiness day.
