For medical device manufacturers selling in the United States, MDSAP participation and FDA inspection are related—but they are not the same regulatory activity.
MDSAP allows a recognized third-party auditing organization to conduct a single audit covering the applicable requirements of participating regulatory authorities. FDA participates in MDSAP and may accept MDSAP audit reports as a substitute for certain routine FDA inspections. However, an MDSAP certificate does not eliminate FDA’s authority to inspect a manufacturer or verify compliance with U.S. requirements.
This distinction has become especially important since FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026.
What Is MDSAP?
The Medical Device Single Audit Program allows one recognized auditing organization to conduct a regulatory audit of a medical device manufacturer against the requirements applicable to participating jurisdictions.
The program currently includes:
- United States
- Canada
- Australia
- Brazil
- Japan
An MDSAP audit evaluates the manufacturer’s quality management system and applicable regulatory requirements through a structured audit model.
For manufacturers operating internationally, MDSAP can provide a way to support regulatory oversight across multiple markets through a coordinated audit program.
Participation is voluntary for manufacturers regulated by FDA.
What Is an FDA Inspection?
An FDA inspection is conducted under FDA’s statutory authority to determine whether a manufacturer is complying with applicable U.S. laws and regulations.
Since February 2, 2026, FDA no longer uses the former Quality System Inspection Technique (QSIT) for medical device inspections. FDA now uses the inspection process described in Compliance Program 7382.850, which aligns with the QMSR.
The change is important because manufacturers should no longer prepare only around the old QSIT framework.
FDA investigators may review the manufacturer’s QMS records and other records relevant to FDA requirements, including records related to management review, quality audits, and supplier audits.
MDSAP vs FDA Inspection
The easiest way to understand the difference is to look at who performs the audit, what the audit is designed to establish, and how the results are used.
| MDSAP Audit | FDA Inspection |
|---|---|
| Conducted by a recognized third-party auditing organization | Conducted by FDA investigators |
| Voluntary manufacturer participation | FDA has statutory inspection authority |
| Covers applicable MDSAP jurisdictions | Focuses on U.S. FDA requirements |
| Uses the MDSAP audit model | Uses FDA’s QMSR inspection process |
| Can support multiple regulatory authorities | Supports FDA regulatory oversight |
| FDA may accept the report for routine inspection purposes | FDA directly evaluates compliance |
FDA specifically states that its QMSR inspections will not follow the MDSAP audit plan or procedures.
That means a company should not assume that preparing for an MDSAP audit automatically means it is fully prepared for an FDA inspection.
How QMSR Changes the Picture
QMSR became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference into 21 CFR Part 820, while maintaining additional FDA requirements.
This creates greater alignment between FDA’s QMS requirements and the quality systems used by manufacturers in international markets.
But alignment does not mean the requirements are identical.
FDA explains that where ISO 13485 conflicts with the FD&C Act or applicable FDA regulations, the U.S. law and regulations control. Manufacturers must therefore consider the complete FDA regulatory framework rather than relying only on ISO 13485 certification.
An ISO 13485 Certificate Is Not Enough
One of the most important points for U.S. manufacturers is that an ISO 13485 certificate does not replace FDA oversight.
FDA has explicitly stated that it will not require ISO 13485 certification and will not issue an ISO 13485 certificate as the result of an FDA inspection.
Similarly, an ISO 13485 certificate does not exempt a manufacturer from an FDA inspection.
The same principle should be kept in mind when evaluating MDSAP.
A manufacturer can have a successful third-party audit and still need to be prepared for direct FDA regulatory oversight.
Does MDSAP Replace FDA Inspections?
The answer is sometimes, but not universally.
FDA may accept MDSAP audit reports as a substitute for routine FDA inspections. This can reduce the need for certain routine inspections for participating manufacturers.
However, MDSAP does not remove FDA’s inspection authority.
FDA’s current QMSR FAQ specifically states that an MDSAP certificate does not exempt a manufacturer from an FDA inspection. FDA inspections may also be conducted based on risk and other regulatory considerations.
Manufacturers should therefore treat MDSAP as a valuable regulatory oversight mechanism—not as an immunity from FDA inspection.
What FDA May Review Under QMSR
The transition to QMSR changes what U.S. manufacturers should have ready for an inspection.
FDA may review records that demonstrate how the company’s QMS operates in practice.
These can include:
- Management review records
- Internal quality audit records
- Supplier audit records
- CAPA records
- Complaint records
- Nonconformity investigations
- Design and development records
- Production and process controls
- Risk management documentation
- Training and competency records
- Purchasing and supplier controls
- Quality objectives and monitoring
- Relevant postmarket information
Importantly, FDA has stated that management review, quality audit, and supplier audit reports may be inspected under QMSR. The previous exceptions under the former QS regulation are not maintained in the same way.
That means manufacturers should avoid treating internal audit and management review records as documents that will never be requested by FDA.
MDSAP and FDA Look at the Same QMS Differently
A mature quality system should be able to withstand both types of scrutiny.
For example, consider CAPA.
An MDSAP audit may evaluate whether the CAPA process is established, implemented, and effective within the organization’s QMS and applicable regulatory requirements.
During an FDA inspection, investigators may examine the same CAPA system but also consider whether the manufacturer’s practices comply with the specific requirements applicable under U.S. law.
The underlying records may be similar, but the regulatory purpose and inspection authority are different.
This is why simply preparing for an MDSAP audit by creating documents is not enough.
The system must actually work.
Common Gaps U.S. Manufacturers Should Watch
1. Treating ISO 13485 as the Entire FDA Requirement
QMSR incorporates ISO 13485, but manufacturers still need to account for applicable FDA-specific requirements.
2. Assuming MDSAP Means FDA Compliance Is Finished
MDSAP can support FDA oversight, but it does not eliminate FDA’s authority or all potential inspections.
3. Weak Internal Audit Records
If internal audits identify the same issues repeatedly without effective CAPA, the problem is no longer simply an audit finding—it may indicate a systemic QMS weakness.
4. Incomplete Supplier Controls
Manufacturers should be able to demonstrate how suppliers are evaluated, monitored, and re-evaluated based on risk and applicable requirements.
5. CAPA Without Effectiveness
Closing a CAPA because an SOP was revised or an employee was retrained does not necessarily demonstrate that the underlying problem was corrected.
6. Management Review That Is Only Administrative
Management review should demonstrate meaningful evaluation of QMS performance, quality objectives, complaints, CAPA, audit results, resources, and opportunities for improvement.
How U.S. Device Makers Should Prepare
Manufacturers can prepare for both MDSAP and FDA oversight by building one strong, integrated QMS rather than maintaining separate systems.
Start with a regulatory gap assessment covering:
QMSR + ISO 13485 + FDA-specific requirements + applicable product regulations
Then evaluate whether your records demonstrate that the procedures are actually implemented.
A practical preparation exercise should include:
- Review your QMS against current QMSR requirements.
- Map FDA-specific requirements that go beyond the core ISO framework.
- Review internal audit findings and recurring issues.
- Evaluate CAPA effectiveness.
- Review supplier controls and supplier audit records.
- Verify management review is complete and meaningful.
- Conduct a mock FDA inspection using current QMSR expectations.
- Confirm employees can explain their processes and responsibilities.
- Make sure objective evidence is easy to retrieve.
- Review previous MDSAP findings for issues that could also attract FDA attention.
What About Existing MDSAP Findings?
Manufacturers should not assume that an issue identified during MDSAP is isolated to the MDSAP audit.
If an auditor identifies a recurring documentation, CAPA, supplier, validation, or risk-management weakness, the manufacturer should determine whether the issue exists elsewhere in the QMS.
A strong response is not simply:
Finding → Correction → Close
Instead, consider:
Finding → Root Cause → Systemic Assessment → CAPA → Implementation → Effectiveness Check
This approach provides stronger evidence that the company is controlling the underlying problem.
A Better Inspection-Readiness Strategy
The goal should not be to maintain one QMS for MDSAP and another for FDA.
Instead, manufacturers should build a QMS that can support:
- ISO 13485 requirements
- MDSAP regulatory requirements
- QMSR
- FDA-specific device regulations
- Product-specific obligations
- Postmarket requirements
This makes the organization less dependent on the format of a particular audit.
If an MDSAP auditor arrives, the system should be ready.
If FDA investigators arrive, the same underlying system should still demonstrate effective control.
Bottom Line
MDSAP and FDA inspections overlap significantly in the quality-system areas they examine, but they are not interchangeable.
MDSAP is a voluntary, third-party regulatory audit program that can support oversight across participating jurisdictions. FDA inspections are direct regulatory inspections conducted under FDA authority.
With QMSR now effective, U.S. device manufacturers should prepare for FDA inspections using the current QMSR framework and FDA’s updated inspection process—not simply the old QSIT model or an MDSAP checklist.
The strongest strategy is to build a QMS that works under both forms of scrutiny.
JJCC Group can help medical device manufacturers assess QMSR readiness, align ISO 13485 and FDA requirements, prepare for MDSAP audits, conduct mock FDA inspections, and strengthen CAPA, supplier controls, internal audits, and management review before an inspection occurs.
