FDA QSR Compliance

FDA Compliance Counsel for Medical Device Manufacturers that Must Comply with the FDA’s Quality System Regulation (QSR) and Upcoming Quality Management System Regulation (QMSR)

The U.S. Food and Drug Administration (FDA) enforces several laws and regulations within the medical device industry. These include the Quality System Regulation (QSR) that currently appears in 21 CFR Part 820. While the FDA announced that the QSR will be replaced by the Administration’s new Quality Management System Regulation (QMSR) in 2026, in its announcement, the FDA also made clear that, “[u]ntil then, manufacturers are required to comply with the [QSR].”

Thus, while medical device manufacturers need to prepare to comply with the new QMSR in 2026, they must also ensure that they are fully complying with the QSR. At Oberheiden P.C., we are actively assisting device manufacturers with both QSR and QSMR compliance. We are helping manufacturers implement and manage effective QSR compliance programs to meet their current regulatory obligations; and, in doing so, we are helping them implement policies and procedures as quality management systems that will allow for a seamless transition to QMSR compliance when the FDA’s new regulations take effect on February 2, 2026.

What Medical Device Manufacturers Need to Know About FDA QSR Compliance

Today, the QSR is a core component of the FDA’s regulation of the medical device industry. It is the source of the FDA’s Current Good Manufacturing Practice (CGMP) requirements—which themselves are essential to FDA medical device compliance. Here, however, we are focusing on the non-CGMP aspects of the Quality System Regulations.

As the QSR makes clear, meeting all relevant requirements is essential to effective compliance management. However, as the QSR also makes clear, not all requirements apply to all medical device manufacturers:

“The [QSR requirements] govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The[y] are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act . . . . If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.”

Thus, for medical device manufacturers, a key first step toward establishing QSR compliance is determining which regulatory requirements apply. These requirements fall into several categories, including (but not limited to):

Quality System Requirements (QSR Subpart B)

Subpart B of the QSR establishes specific requirements for medical device manufacturers’ quality systems. Some examples of the numerous requirements in this section of the QSR include:

• “Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.”
• “Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.”
• “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.”
• “Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements . . . .”
• “Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.”

Design Controls (QSR Subpart C)

The QSR also establishes several requirements regarding the design of medical devices. These requirements apply to all Class II and Class III devices, as well as the Class I devices listed in the QSR. Obligations imposed by Subpart C of the QSR include (but are not limited to) those pertaining to:

• Design and development planning
• Design input
• Design review
• Design verification
• Design validation 

Document Controls and Records (QSR Subparts D and M)

Subparts D and M of the QSR establish requirements pertaining to the generation and storage of various forms of documentation. For example, Subpart D provides that, “[e]ach manufacturer shall establish and maintain procedures to control all documents that are required by this part,” while Subpart M provides that, “[a]ll records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA . . . .” Under Subpart M, manufacturers must retain all required records for a minimum of two years (subject to certain exceptions); and, for records deemed confidential, manufacturers must include markings, “to aid FDA in determining whether information may be disclosed under the public information regulation” of the QSR.

Identification and Traceability (QSR Subpart F)

Subpart F of the QSR establishes general requirements for identification and traceability of covered medical devices. The identification requirements apply to all medical devices, while the traceability requirements apply specifically to surgical implants, life-sustaining devices, and other devices “whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user.” These are some of the most general requirements in the QSR, which leaves it to device manufacturers (and their counsel) to determine what measures are necessary to adequately effectuate compliance.

Labeling and Packaging Control (Subpart K)

Subpart K of the QSR establishes requirements pertaining to the labeling and packaging of medical devices. It is important to keep in mind, however, that these are not the only labeling and packaging requirements that apply—and this non-comprehensiveness is mirrored in various other subparts of the QSR as well. In fact, when it comes to labeling and packaging, the QSR’s requirements represent just a small sampling of legal and regulatory requirements enforced not only by the FDA, but by other federal authorities as well. Some examples of the labeling and packaging requirements in the QSR include:

• “Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.”
• “Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions.”
• “Each manufacturer shall control labeling and packaging operations to prevent labeling mixups.”
• “Where a control number is required . . . that control number shall be on or shall accompany the device through distribution.”
• “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”

Again, this is a non-exhaustive list of the topics covered in the QSR. The regulation also includes provisions pertaining to production and processing, corrective and preventive action, and various other activities and events within the product manufacturing lifecycle. At Oberheiden P.C., we assist medical device manufacturers with all aspects of QSR compliance, and we take a custom-tailored approach focused on ensuring that we comprehensively address each of our clients’ specific obligations and needs.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: FDA QSR Compliance for Medical Device Manufacturers

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If you need to know more about QSR compliance (or QMSR compliance), we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a free consultation with an FDA compliance lawyer at Oberheiden P.C.