Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

The Quality System Regulation (QSR) was set up by the U.S. Food and Drug Administration (FDA) to create guidelines for ensuring quality, safety, and efficacy in the development and manufacture of medical devices. These are detailed in 21 CFR Part 820. Simply put, a quality device is the safest and most effective version the product.

To improve the efficiency of inspection processes, the FDA implemented the Quality System Inspection Technique (QSIT). This technique provides guidance for the agency’s field staff to use in assessing the manufacturer’s compliance with the QSR. While there are many components in the medical device regulatory process, accurate and up-to-date records are an essential part of demonstrating compliance. This post takes a deep dive into the requirements for records management.

Device Master Record (DMR)

The DMR is defined in 21 CFR 820.3(j) as a compilation of records containing the procedures and specifications for a finished device. Each DMR should include or refer to the location of the following information:

• Device specifications: Includes appropriate drawings, composition, formulation, component specifications, and software specifications.
• Production process specifications: Includes the appropriate equipment specifications, production methods, production procedures, and production environmental specifications.
• Quality assurance procedures: Includes the acceptance criteria as well as the quality assurance equipment to be used.
• Packaging and labeling specifications: The required processes that apply to product packaging and labeling.
• Installation, maintenance, and servicing: The procedures and methods involved in installation, maintenance, and servicing processes.

Device History Record (DHR)

The DHR is defined in 21 CFR 820.3(i) as a compilation of records containing the production history of a finished device. Basically, the DHR provides the information necessary to document the production history of a particular batch, lot, or unit. The DHR should include or refer to the location of:

• The dates that products are manufactured.
• The quantity of devices manufactured.
• The quantity of devices released for distribution.
• The acceptance records that demonstrate the device was manufactured in accordance with the DMR.
• The primary identification label and labeling used for each production unit.
• Any device identification and control numbers used.

Design History File (DHF)

The DHF is defined in 21 CFR 820.30. The file serves as the repository of documentation generated by the design control process. Below is a list of documents that should be in the DHF:

• Design and development planning.
• Design input.
• Design output.
• Design review.
• Design verification.
• Design validation, with software validation if applicable.
• Design transfer.
• Design changes.

Because the DHF is the collection of the documentation showing the evolution of the design, it must be assembled and updated properly as it will be referenced throughout the life cycle of the product.

Quality System Record (QSR)

The QSR is defined in 21 CFR 820.186, which points to the location of procedures and the documentation, activities, and other records required by the QSR that are not specific to a particular device or family of devices. Manufacturers need to ensure they prepare the QSR and get it approved according to the 21 CFR 820.40 document controls. These include guidelines for document approval, distribution, and document changes.

Complaint Files

Defined in 21 CFR 820.198(a), a complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. For compliance, a medical device manufacturer must retain complaints in a specific file. Companies must also establish procedures for receiving, reviewing, and evaluating complaints. To comply with complaint handling procedures, a manufacturer must:

• Process all complaints in a timely manner.
• Immediately document and file verbal complaints.
• Evaluate every complaint to determine whether it represents an event that must be reported to the FDA.

Records Maintenance Guidelines

In addition to creating the records required for the QSR, the FDA established the following guidelines for properly maintaining them:

• Accessibility: The FDA expects that records required by the QSR be available within a reasonable timeframe before and during the course of an inspection. Paper records requested during an inspection must be available for review within the next one or two working days at the latest.
• Legibility and storage: Manufacturers should ensure that records are legible and stored in such a way as to minimize deterioration and loss. Records stored in automated data processing systems must have secure backups.
• Confidentiality: Companies may mark documents confidential to help the FDA in determining whether the information may be disclosed under the Public Information Regulation (21 CFR Part 20). Still, the FDA may not consider all records stamped “Confidential” to be confidential.
• Retention period: All records required for the QSR must be retained for a period of time equivalent to the design and expected life cycle of the device. The FDA believes the retention of these documents is necessary because manufacturers may need such records when performing investigations.

The records required in medical device manufacturing can be numerous and lengthy. A digitized, platform-based quality management system (QMS) makes it easier for medical device companies to keep their records and management processes audit-ready. A paperless system enables you to stay a step ahead of any audit because you create, track, and update all critical records and other documentation in a central repository. You can immediately access any document upon request, and you can allow auditors to have limited access to select documents.