AccuReg Special Report: Design Control Update

Special Report: Design Control Regulations

By Kenneth F. Miles, PhD, RAC

Well, it finally happened. The Food and Drug Administration (FDA) has revised the current Good Manufacturing Practice (cGMP) requirements for medical devices and incorporated them into a quality system regulation.

Starting June 1, 1997, manufacturers will be inspected for compliance with all the new quality system requirements, including design controls. Manufacturers will be required to take reasonable steps to come into compliance with the new design control requirements by June 1, 1998. Additionally, if a manufacturer has a design in the development stage before June 1, 1997, and cannot comply with the new requirements, the manufacturer must provide a detailed justification as to why compliance is not possible.

The design control section of the GMP regulation, described in Section 820.30, will require device manufacturers to establish and maintain formal controls for their product development activities. These controls are intended to ensure that specifications for the device are developed and thoroughly reviewed, to provide all possible assurance that the device eventually manufactured can be used safely and effectively.

The design control requirements cover nine areas, including:

Design and Development Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Change
Design History File

Following is a discussion of each of the nine phases and their requirements.

Phase 1: Design and Development Planning

The first phase, design and development planning, requires manufacturers to:

Create a plan that identifies and describes the activities necessary to design and develop a device, including a system to update the design as it evolves;
Assign a qualified staff and adequate resources to design and verification activities;
Identify organizational and technical interactions that must occur among the company's departments and between the company and its suppliers;
Establish mechanisms to ensure that necessary information is documented, transmitted and reviewed, as required.

Design and development planning is critical because it establishes the groundwork for the entire design process. The plan makes clear what is going to happen, who is going to make it happen, and when it will happen. If manufacturers do not plan the design process properly from the outset, they set themselves up for numerous potential disasters such as production delays, loss of market share, cost overruns, recalls, lawsuits, or worse.

Phase 2: Design Input

Design input is the backbone of the product development process. In this phase, the manufacturer gathers information about the intended product's performance requirements and defines the preliminary specifications for design characteristics, material compositions, and operational configuration of the product.

The end result of the design input phase is a report that defines the overall design goals and provides an approved set of preliminary specifications for the product to be developed. The report should document all the information required to direct the remaining activities in the design process.

Phase 3: Design Output

As the design phase progresses, the design team moves into the design output stage. Using the specification as a foundation, the team produces one or more fully functional prototypes, and all the documentation required for purchasing, production, installation, testing, inspection and servicing of the finished device.

Design output should also include the test plans, procedures and reports used to verify that a product meets the design input requirements found in the product specification, including regulatory and safety requirements. The design team will use a subset of these documents to prepare the various regulatory submissions needed to obtain the approvals required to market products worldwide.

Phase 4: Design Review

Generally, the purpose of design review is to determined how product development is progressing, to anticipate potential problems with design and process development, and to ascertain that the product and processes are ready to move to the next stage of development. Specifically, the design review stage ensures that:

Product and process documentation are accurate and correspond to specifications;
The final design corresponds to the intended use of the product;
Personnel have been properly trained in production procedures.

The design team can accomplish the review by conducting internal trials or tests, reviewing calculations, and if necessary, conducting external studies such as clinical trials. However, the FDA states that clinical trials should not begin until the safety of the device has been verified under simulated-use conditions, particularly at the expected performance limits.

Phase 5: Design Verification

Design verification refers to a series of procedures used by the product development team to ensure that the product design output meets the design input. Verification starts when the product specifications have been established and continues throughout the design process. The net result of design verification is to confirm, with a high degree of accuracy, that the final product meets specifications, is safe and effective, and performs according to user expectations.

Phase 6: Design Validation

Design validation follows successful design verification and must include the testing of actual production devices under actual or simulated use conditions. Testing cannot be performed on prototypes because the actual devices produced and distributed are seldom the same as the research and development prototypes. Design validation should be performed under defined operating conditions on the initial production units, lots, or batches, or their equivalents, to ensure proper overall design control and proper design transfer. The FDA considers this requirement a critical element of the design validation.

Phase 7: Design Transfer

Design transfer, the final phase of the product development process, is the bridge between product design and product manufacturing. Fundamentally, design transfer involves transferring knowledge in the form of documentation and training from the product development team, which has been designing and developing the product, to the manufacturing group, which will build the product and sustain it throughout its life cycle. The documentation consists of information on the product and the manufacturing process, including component specifications, assembly drawings, software specifications, assembly procedures, equipment calibration instructions, and training requirements. Design transfer stage ensures that the information is accurate and conforms to specifications, and that the people who will manufacture the product have been properly trained.

Phase 8: Design Changes

Design changes made after the initial design is approved in the design review stage, as well as those changes made to correct design deficiencies once the design has been released to production, must be documented. The records of these changes create a design evolution history, which is invaluable for failure investigation and for facilitating the design of similar products in the future.

Phase 9: Design History Files

Finally, the design history files contain or reference all the records necessary to establish compliance with the design plan and GMP regulations, including the design control procedures. The design history files illustrate the history of the design, and allow manufacturers to exercise control over and be accountable for the design process, maximizing the probability that the finished design conforms to the design specifications.

--------------------------------------

By Kenneth F. Miles, PhD, RAC
Special to The Regulatory Forum

Editor's note: The new Device GMPs were published in the Federal Register on October 7, 1996. The effective date for the revised regulations is June 1, 1997, but as noted by Dr. Miles, special provisions apply to the new Design Control requirements in Section 820.30 of the Final Rule. Specifically, as long as manufacturers are taking reasonable steps to come into compliance, FDA will implement a special 1-year transition program, with a mid-course review, during which official Agency action will not be initiated, including FDA Form 483 observations, Warning Letters, or enforcement cases, based on failure to comply with Section 820.30. Beginning June 1, 1998, FDA will treat non-compliance with the Design Control requirements the same as non-compliance with other provisions of the cGMP regulation.

For additional information about the new design control regulations, see the Special Report entitled, "Medical Device GMP Update" at The Regulatory Forum.

For more information about implementation of the Final Rule, review Section IV of the Supplementary Information published at 60 FR 52062. To obtain a copy of the new regulation, including the Supplementary Information, download a copy from the Regulatory Forum or FDA's Web Site.

7501 Northwest 4 Street, Suite 210
Plantation, Florida 33317, USA
Telephone: 954-641-6400 Fax: 954-641-6410
Email: accureg@regulatory.com

Contact webmaster