History of FDA Medical Device Regulation

Establishment of Medical Device GMP

On July 21, 1978, the FDA issued a final rule in the Federal Register (43 FR 31508), establishing current Good Manufacturing Practice (cGMP) requirements for medical devices (Medical Device GMP) under Section 520(f) of the FD&C Act.

The regulation became effective on December 18, 1978, and was codified under Part 820.

Why Medical Device GMP Was Changed to QSR

GMP stands for Good Manufacturing Practice. In the pharmaceutical industry, most recall cases are attributable to manufacturing quality issues. However, in the case of medical devices, even if a device is manufactured properly according to the drawings, it will not be a safe medical device if the design itself is flawed.

In other words, appropriate design control is necessary to ensure the safety of medical devices.

Safe Medical Devices Act (SMDA)

The GMP regulation published on July 21, 1978, established requirements for the manufacture and quality control of medical devices, but there were few changes until the Safe Medical Devices Act (SMDA) was enacted in 1990.

The SMDA was enacted based on the finding that a significant proportion of device recalls were attributable to product design defects.

The SMDA called for the incorporation of design control requirements into the GMP regulation and efforts toward mutual recognition agreements on GMP with foreign countries.

Under the SMDA, the FDA gained the authority to add design controls to the cGMP regulations.

The FDA revised the GMP regulation under the SMDA to add new design control provisions while simultaneously adopting a policy of aligning the GMP regulation as much as possible with the quality system requirements included in the international standard (ISO 9001).

From Medical Device GMP to QSR

The movement to revise the GMP regulation began with the convening of the Medical Device GMP Advisory Committee in April 1990.

From that year through 1995, various procedures progressed toward regulatory revision, including publication of an Advance Notice of Proposed Rulemaking, publication of a proposed rule seeking public comments, publication of a GMP Working Draft and requests for comments on the draft, holding of GMP public hearings, and convening of the GMP Advisory Committee. With the addition of analysis of device recall data and evaluation of international quality standards, the FDA decided to revise the Medical Device GMP.

To implement the changes mandated by the SMDA, the FDA revised Part 820 in 1996, establishing the current Quality System Regulation (QSR).

Because the Medical Device GMP regulation had to be applied to many different types of medical devices, the FDA determined that it was more rational to establish a broad framework that all manufacturers must follow rather than to prescribe in detail the manufacturing requirements for specific devices.

In accordance with this principle, the FDA published a new regulation called the Quality System (QS) on October 7, 1996, as the final GMP regulation, with changes to the proposed regulation and the working group draft to give manufacturers flexibility in achieving quality requirements.

The QSR was developed based on ISO 13485:1996/ISO 9001:1994.

The QSR includes requirements for procedures used in the design, purchasing, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices, as well as requirements for the facilities and controls used for these activities.

From the time the QSR was established, the FDA aimed to harmonize the cGMP regulations as much as possible with the quality management system requirements included in the international standards applicable at that time.

The FDA worked closely with the Global Harmonization Task Force (GHTF) and ISO Technical Committee 210 (TC 210).

In the definition of the regulation, Quality refers to the totality of features and characteristics that support a device’s ability to satisfy fitness-for-use, including safety and performance, and QS (Quality System) refers to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

From QSR to QMSR

On February 23, 2022, the FDA published a proposed rule to align the QSR with ISO 13485:2016.

The regulation that aligns the QSR with ISO 13485:2016 is called the “Quality Management System Regulation (QMSR).”

The QMSR is intended to align many requirements with ISO 13485:2016 by incorporating the requirements of ISO 13485:2016.

At the same time, it adds additional requirements beyond ISO 13485:2016 regarding the retention of records such as complaint files.

The FDA issued the QMSR as a final rule on January 31, 2024 (published in the Federal Register on February 2, 2024), with an effective date of February 2, 2026. This provided a two-year transition period for manufacturers to prepare for the new requirements. The QMSR represents a significant regulatory modernization effort, incorporating by reference the internationally recognized ISO 13485:2016 standard while maintaining specific FDA requirements necessary to comply with U.S. law.

Key Changes Under QMSR

The transition from QSR to QMSR represents a fundamental restructuring of Part 820:

Regulatory Structure: The QMSR significantly reduces the written content of Part 820, condensing it from 15 subparts (A-O) under the QSR to just two subparts (A and B) under the QMSR. Most existing requirements are now replaced by references to ISO 13485:2016, with many sections marked as “Reserved” for potential future FDA additions.

Incorporation by Reference: The QMSR formally incorporates by reference ISO 13485:2016 (Medical devices—Quality management systems—Requirements for regulatory purposes) and Clause 3 of ISO 9000:2015 (Quality management systems—Fundamentals and vocabulary), making compliance with these international standards a legal requirement rather than a voluntary option.

Risk-Based Approach: One of the key differences between the QSR and QMSR is the explicit requirement in ISO 13485:2016 to “apply a risk based approach to the control of the appropriate processes needed for the quality management system” (ISO 13485:2016, Subclause 4.1.2(b)). This requires manufacturers to document their overarching risk-based approach to QMS development and control.

Additional FDA Requirements: While incorporating ISO 13485:2016, the QMSR includes specific FDA requirements that extend beyond the scope of ISO 13485, particularly regarding:

Labeling and packaging activities (extending beyond ISO 13485 Clause 7.5)
Complaint file retention and management
Specific documentation and record-keeping requirements aligned with U.S. regulatory expectations

Inspection Authority: Under the QMSR, the FDA gains authority to inspect management review, quality audits, and supplier audit reports. The exceptions that existed in the QSR at §820.180(c) are not maintained in the QMSR, expanding FDA’s inspection scope.

Implementation Timeline and Guidance

Effective Date: The QMSR becomes effective on February 2, 2026. Until that date, manufacturers must continue to comply with the QSR.

Transition Period: The FDA provided a two-year transition period from the final rule publication (February 2, 2024) to the effective date (February 2, 2026). However, there is no additional enforcement discretion period beyond the effective date.

Draft Guidance: On October 27, 2025, the FDA issued its first draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews.” This guidance provides recommendations for QMSR information to be included in Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications. Comments on this draft guidance were accepted until January 16, 2026.

Technical Amendments: On December 4, 2025, the FDA published technical amendments updating references throughout 21 CFR from the QSR to the QMSR. These amendments modify 179 sections across 18 parts of Title 21 CFR to ensure consistency with the QMSR, including updates to device classification regulations and various procedural references.

Premarket Submissions: Applications received before February 2, 2026, must demonstrate compliance with the QSR, while applications received after that date must demonstrate compliance with the QMSR. Manufacturers planning submissions in late 2025 or early 2026 should carefully consider the timing of their submissions relative to their QMS transition status.

Benefits and Impact

The FDA estimates that the QMSR will result in significant cost savings for the medical device industry:

Approximately $532 million in annualized net cost savings at a 7% discount rate (cost savings: $540M, costs: $8.2M)
Approximately $554 million in annualized net cost savings at a 3% discount rate (cost savings: $561M, costs: $7.29M)

Beyond financial benefits, qualitative benefits include:

Quicker access to newly developed medical devices for patients, leading to improved quality of life
Greater regulatory harmonization with international standards, facilitating global market access
Reduced redundancy in compliance efforts for manufacturers operating in multiple jurisdictions
Support for the Medical Device Single Audit Program (MDSAP), in which the FDA and regulatory authorities from four other countries participate

Preparing for QMSR Compliance

Manufacturers should take the following actions to prepare for QMSR implementation:

Gap Assessment: Conduct a comprehensive assessment to evaluate which processes and procedures require adjustment to comply with the QMSR and ISO 13485:2016.
Documentation of Risk-Based Approach: Ensure that the overarching risk-based approach used in developing the QMS is thoroughly documented, as this is a key requirement under ISO 13485:2016 that differs from the QSR.
Procedure Updates: Prepare new draft procedures or amendments to existing procedures that align with the QMSR for implementation by February 2, 2026.
Personnel Training: Train personnel on the key differences between the QSR and QMSR and on new or updated procedures for QMSR implementation.
Supplier Management: Work with suppliers to amend quality agreements to align with the new QMSR requirements. Consider which suppliers may require updated supplier audits to assess QMSR readiness.
Risk Management Alignment: While FDA is not incorporating ISO 14971 (Medical devices—Application of risk management to medical devices) by reference within the QMSR, ISO 13485:2016 incorporates terms and principles from ISO 14971. Manufacturers should assess the extent to which their risk management processes and procedures comply with ISO 14971 to demonstrate compliance with ISO 13485:2016.
ISO 13485 Certification Consideration: Note that ISO 13485:2016 certification alone will not exempt manufacturers from FDA inspections. Manufacturers will still be assessed according to the FDA’s updated inspection model, which will revise Quality System Inspection Technique (QSIT) methodologies to align with the new QMSR framework.

Accessing Required Standards

ISO 13485:2016 is available for download on the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal, though registration is required. ISO 9000:2015 can be accessed through the ISO Online Browsing Platform, but is not available for download.

Relationship with Other Regulatory Programs

The QMSR supports the FDA’s participation in the Medical Device Single Audit Program (MDSAP), which allows for a single audit to satisfy the regulatory requirements of multiple participating regulatory authorities. The alignment with ISO 13485:2016 facilitates regulatory harmonization and reduces the burden on manufacturers operating in multiple international markets.

The QMSR also reflects the FDA’s broader commitment to international regulatory convergence and modernization of device oversight while maintaining alignment with statutory obligations under the FD&C Act and the quality system requirements that support cGMPs.

Future Updates

When ISO 13485 is revised in the future, the FDA will need to initiate a new notice-and-comment rulemaking to update the QMSR to incorporate the new version. The agency will be unable to enforce the new version until the new rule becomes effective through the standard federal rulemaking process.

Note: This article reflects the regulatory landscape as of January 2026. Manufacturers are encouraged to monitor FDA communications and guidance documents for the latest updates as the February 2, 2026 effective date approaches and during the implementation phase.

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