FDA leverages international Quality Management System (QMS) policies

Management of Medical Device QMS and Risk Assessment poised to become more agile

Ajit Rajshekar & Sandeep Kumar
Published: May 9, 2022

The medical device industry is continuously undergoing global and digital transformation. As this shift takes place, the Food and Drug Administration (FDA) recognized the need for more internationally aligned manufacturing quality process so that medical devices in the U.S. are safe and effective throughout their product lifecycle. The new quality management system policies align more with the International Standards Organization (ISO) standards and aim to strengthen the controls for labeling, packaging operations, and documentation to reduce product recalls with a renewed emphasis on medical device reporting and risk management.

Food and Drug Administration (FDA) and International Standards Organization (ISO) policies

In 1978, the FDA issued the current good manufacturing practice (CGMP) as a final rule for requirements in the Federal Register. As part of the CGMP, the quality management system (QMS) was formed and recorded in the Code of Federal Regulations, 21 CFR part 820. These requirements help manufacturers consistently ensure their products meet applicable customer and regulatory requirements and specifications. The CGMP has not been revised in recent years. 

In contrast, International Standards Organization (ISO) is a ‘voluntary’ standard by an independent non-governmental organization. The ISO’s influence has evolved, and major medical device regulatory bodies worldwide follow it. Since its first version of the ISO 13485 quality management system standard was released in 1996, it has consistently tried to converge the ISO 9001 principles and QMS-related requirements for manufacturers involved in one or more stages of the medical device lifecycle.

Global harmonization for the medical device industry 

The FDA recognized the value of global device regulation long ago. The agency helped develop international documents and standards for risk management. The recent proposal aligns with the ISO to continue to promote the production of high-quality medical devices.

The FDA’s proposal uses the 2016 edition of the ISO 13485 quality management system standard to incorporate an international standard for medical device quality management systems. Additionally, it clarifies the device CGMP requirements for combination products by aligning requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations and making edits to the Code of Federal Regulations  (21 CFR part 820).

Medical device manufacturers can submit comments and recommendations about the proposed rule by May 24, 2022. These rules go into effect one year after the date of publication of the final rule in the Federal Register.

Click on the proposal number for more information Federal Register

Incorporation by Reference

  • FD&C Act to be deciding regulation in case of any conflicts between ISO and the FD&C Act
  • Adopting best practices of risk-based decision making (to be led by top management) and the breadth of it in the QMS, from ISO 13485


  • Defines the terms missing in ISO but deemed necessary by FDA 

a) Addition of “Federal Food, Drug, and Cosmetic” definition

b) Replacing the term “management with executive responsibility” with the term “top management” 

c) Retaining definition of "rework", with change to term “device master record (DMR)” 

d) Retaining without change the terms and definitions for “component”; “finished device”; “human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device”; “design validation"; “remanufacturer”; “nonconformity”; and “verification”

  • Defines terms from ISO that are not incorporated

a) Definitions of "Device"; "Labelling"; and "Manufacturer"

Proposed Requirement for a Quality Management System

  • Relocate/revise this provision of QMS that complies with ISO 13485
  • Requirement of the manufacturer to record quantitative data
  • Regulated manufacturer to comply with 'applicable' requirements in ISO 13485
  • Clause 7.3 Design and Development of ISO to be required by Class I devices listed in provision (along with Class II and Class III devices)
  • Life sustaining devices to comply with traceability requirements set forth in Clause for implantable medical devices (in ISO 13485)

Proposed Clarification of Concepts

  • Clarification to concept of Organization"; "Safety and Performance"; "Validation of Process"

Proposal for Control of Records

  • Proposes additional requirements from ISO 13485) to ensure consistency and alignment - Including signature and date requirements for records; Additional requirements for Medical Device Reporting, Documentation around Unique Device Identification and Confidentiality of documents that FDA receives.

Proposed controls for Device Labelling and Packaging

  • Proposes additional requirements from ISO 13485 (Clause 7.5.1(e)) related to device recalls because of Labelling and Packaging.
  • FDA to retain the authority of inspection of Labelling.


Benefits of FDA’s new approach

The FDA's modifications focus on quality throughout the manufacturing process by recognizing manufacturers as organizations with impetus on safety and effectiveness. Medical device reporting undergoes a transformation by extending the unique document ID and maintenance and signoff of records into digital formats. The integration of risk management activities throughout the QMS and establishing accountability on top management will certainly improve device quality. The change strengthens controls for labeling and packaging operations, given that many device recalls are related to labeling and packaging. The FDA also retains its inspectional authority. 

Documentation policies also get a revamp. The FDA goes a step further to specifically call out that manufacturers record quantitative data as appropriate because such information assists manufacturers in monitoring the performance of their processes and the effectiveness of their process controls. It proposes to add a requirement for the devices that support or sustain life. If these devices fail to perform when used according to the instructions on the label can result in significant injury. The new requirement complies with traceability requirements for implantable medical devices set by the ISO.

The FDA recognizes substantial similarities in intent with the ISO while keeping an upper hand on some conflicting areas. The FDA taking steps to harmonize global manufacturing renews its commitment to upholding the safety standards of consumers. At the same time, the agency is not diluting its own rulebook too much. Doing so allows them to continue to emphasize proper maintenance, repair, and servicing of medical devices. All of which, as the FDA states,  are “critical to maintaining the safe, effective, and reliable performance of devices”. This is an attempt from the regulatory body to keep the best of both worlds and make the consumers the real benefactors.

Impact on digital transformation 

From a digital point of view, though this does not seem to disrupt existing QMS systems for the device manufacturing organizations, the impact is inevitable. With FDA timeboxing this to come to effect one year from the publish date, the changes to existing design, development, and V&V processes, and therefore, the existing IT systems and processes need to be done swiftly.

With increased focus on risk assessment and focus on maintaining design records and gating signoffs puts pressure on manufacturing organizations to enhance their existing design history files, device master records, and archival processes. The FDA’s push for manufacturers to even lookout for some not-so-explicit requirements leads the IT systems of these organizations to adopt a more agile approach to their ever-evolving QMS. With many new regulations coming to light as and when the organizations learn more in due course.

Global standards improving medical device quality

The FDA’s proposal to align with the ISO standards improves medical device quality across the industry. Ensuring safety and effectiveness throughout the product lifecycle with a strengthened medical device quality management system improves medical devices available in the U.S. and overall patient care. The life sciences and healthcare industries will benefit from the FDA's proposal to strengthen labeling and packaging operations controls and accept digital medical device reporting.

Ajit Rajshekar

Ajit Rajshekar

Associate Director – Intelligent Automation

Ajit Rajshekar is a test architect with over 15 years of quality engineering experience, mainly in the product engineering domain (medical devices). His interests include exploring and using new methodologies/tools in test automation and cognitive intelligence (AI/ML) in testing.

Sandeep Kumar

Sandeep Kumar

Manager, Business Consulting
Medical Devices & Digital Health

Sandeep leads the product lifecycle and the release strategy of medical devices for a leading manufacturer in the U.S. market. He has also led clinical operations quality initiatives in the past. He works closely with domain leaders and technology experts to deliver important turnkey projects, along with consulting on several proposals and the GTM strategy.

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