FDA is becoming more and more perceptive when it comes to addressing design controls during an inspection of your Quality Management System (QMS). Let’s go back in time to 1997 when FDA indicated that “starting on June 1, 1997, manufacturers will be inspected for compliance with all the new quality system requirements, including design controls, in the manner described in the inspectional strategy.”
The Transition: As part of the transition program, for a period of one year, although FDA inspected firms for compliance with the design control requirements, the field issued any observations to the manufacturer on a separate design control inspectional strategy report, not on FDA Form 483. The time period from June 1, 1997 to June 1, 1998 was intended to allow both the industry and FDA field investigators time to become familiar with the design control requirements and the enforcement aspects of this new area.
Strategy Reports: The completed strategy reports were reviewed with particular attention paid to clearness of information obtained, the appropriateness of the information collected with respect to the design control requirements, the appropriateness of the questions on the inspectional strategy, the manner in which the investigators are writing out their observations and any requirements that seem to be giving manufacturers a problem, or instances in which there might be misunderstandings as to what the regulation required. Industry was apprehensive.
Important to Note: The design control requirements are not intended to apply to the development of concepts and feasibility studies. However, once it is decided that a design will be developed, a plan must be established to determine the suitability of the design requirements and to ensure that the design that will eventually be released to production meets the approved requirements. FDA investigators will not inspect a device under the design control requirements to determine whether the design is appropriate or “safe and effective.” Section 520(f)(1) (a) of the Food, Drug and Cosmetic Act (The Act) precludes FDA from evaluating the “safety or effectiveness of a device” through preproduction design control procedures. FDA investigators will evaluate the process, the methods and the procedures that a manufacturer has established to implement the requirements for design controls. Based on any information gained during an inspection, if an investigator believes that distributed devices are unsafe or ineffective, the investigator has an obligation to report the observations to the Center for Devices and Radiological Health (CDRH).
Now…Dial up Fourteen Years: The design control requirements of Section 820.30 of the regulation apply to the design of Class II and III medical devices, and a select group of Class I devices. The regulation, in the area of design controls, gives manufacturers just enough rope to hang themselves. The type of design control system and the details of implementation are left for each company to decide based upon the complexity and risks associated with their devices. During an inspection, much attention is paid to these linkages as part of the total process architecture:
- Design and development planning versus what information ends up in the design history file
- Identifying design inputs and then the essential outputs
- Verification work that could eventually end up in the design history file as a formal acceptance activity
- Validating the design from a standpoint of the intended use and user needs
- Controlling design changes before and after commercialization
- Reviewing design results versus the original design plan
- Transferring the design to production while realizing the value of concurrent engineering
- Compiling a Design History File as a basis for the Device Master Record
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process. This system of checks and balances is not only used to operate on a day-to-day basis, but also as a platform for planning and carrying out an FDA inspection. For example, as a result of these checks and balances, deficiencies in design input requirements and discrepancies between the proposed designs and requirements are made evident in the development process. An initial challenge during any inspection is to ascertain whether or not design controls will increase the likelihood that the design transferred to production has been translated into a device that is appropriate for its intended use. Also, devices are manufactured by companies varying in size and structure, methods of design and development and methods of management. These factors significantly influence how design controls are actually applied and enabled within the confines of 21 CFR, Part 820. Given this diversity, the checks and balances will vary from company to company within this range of compliance and FDA’s approach has become more flexible to accommodate this playing field.