FDA is looking to make sure that all required elements of a design control system are in place, but more importantly, they are looking to see if the products that companies are developing are following the design control procedures. I believe that an important element of having a complete design control system is how well the company adheres to it design controls. I don't think that FDA issues many findings for an incomplete design control system, because every medical device company knows exactly what design controls need to be in place, so in order to develop a medical device to be cleared by FDA they would have to have a design control system conforming to FDA requirements. However, where companies most often get into trouble is by deviating from their design controls, so I would say FDA is especially focused on looking to see if you are following your own design control procedures.

To add to the discussion I believe that a complete Design Control System maintains the established feedback loop where the product is documented adequately while providing room for improvement along the development stages. The FDA, as previously mentioned, looks to see that the company adheres to their procedures and that they do not stray away from them. Incorrect documentation of stages along the process can result in possible findings. One example I can think of where the process needs to be full proof is during remediation of a product/product line. Although every level within the process should be full proof, remediation must have documentation, personnel, and adherence to procedure otherwise findings can occur.

In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when a company send in a new IND to the FDA for a new drug. They are now just going to investigate to make sure that the design controls around the development and safety of the drug is within standards. I believe that If that drug is being manufactured and going through clinical trials that the equipment, operator/scientist and Protocols behind how this drug is developed is of great importance as well.

I'd also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, and that is why the FDA needs to ensure that the product performs as promised, and is safe to use. However, anything can happen depending on the type of medical product you are using. For instance, a hip implant will be beneficial for a patient who has a bad hip, but its possible that the implant can cause some fatigue over time. For these reasons, its necessary that a risk analysis is developed so that the FDA is aware of the possible risks that can occur. Also, the risk analysis will tell us what procedures will be taken to prevent or stop these issues from occurring. Not every product is perfect, and its essential to know that there is a plan to fix any issues that may arise.

To have an adequate Design Control System - one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF.

For Design Input this includes physical appearance of the device, labeling and packaging, maintenance, functionality, safety. Essentially it is the physical and performance characteristics of the device.
The Design Outputs are the results of the total design effort. It consist of definable and acceptable criteria and conformance to whatever the design inputs were
The Verification is evidence and confirmation that the design output meets the design input. Evidence for this includes engineering test and reports.
The Validation is evidence and confirmation that the design specifications of the device meets the user needs and intended uses. Evidence for this includes batch records, lots, first production runs.
Design Transfer are creating the procedures to ensure that the designs are put into production correctly and are maintained.
Risk analysis is documenting and recording any potential hazards, errors, calculated risk under certain conditions, risk acceptability, and identifying changes to reduce identified risk and mitigate new hazards.
DHF is for tracking the design history of a finished device and includes all references and information that was used to design the device from start to finish.

FDA audits will want to look into these type of records therefore it is imperative to establish and track all the constant updating of these documents.

Risk analysis is part of Design Control System and one of the aspects regulatory agencies look for is the integration of risk management to complaint handling. Establishing a risk management file is critical and more importantly is establishing a feedback loop from post market surveillance (e.g. product complaints, complaint investigations, adverse events, track and trending, etc.) to risk management so that decisions about risk mitigations/ controls can be evaluated by actual market performance. I believe this may be one of the challenges in the medical device industry. Recently, Meridian Medical Technologies, Inc. a Pfizer Company that manufactures EpiPen received a warning letter related to several aspects such as failure to properly perform complaint investigations and loop back into the design control system.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm

FDA looks for the following: The quality system: Processes and procedures define and implement to describe how the company addresses medical device regulations. Design History File (DHF): Demonstration of Design Controls throughout the product development process is expected and required. The User Needs of the medical device. Design Output: Roadmap to figuring out how to actually design and develop your medical device. Design Inputs: This define all the performance criteria, requirements, and features of your medical device product.

Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs you define. FDA doesn’t really define User Needs in the 820.30 regulations per se. User Needs are usually displayed in the beginning of the Design Controls as in the waterfall diagram. User Needs are directly tied to the Design Validation and Validation proves if the medical device meets the user Needs.

Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment, According to Federal Regulations 21 CFR 820.30 you need to have a complete Design Control System:-
1) Design Control
2) Design and Development Plan
3) Design Input
4) Design Output
5) Design Review
6) Design Verification
7) Design Validation
8) Design Transfer
9) Design Changes
10) Design History File (DHF)
11) Risk and Hazard Analysis activities

Per the FDA site the regulation dos not prescribe the practices that must be used instead it establishes a framework that manufacturers must use when developing and implementing design controls.

To add to what was posted by hv24, a sample table of contents could be found at the FDA link below:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm

TABLE OF CONTENTS
• FOREWORD i
• PREFACE iii
• ACKNOWLEDGEMENT iv
• TABLE OF CONTENTS v
• INTRODUCTION
• SECTION A. GENERAL
• SECTION B. DESIGN AND DEVELOPMENT PLANNING
• SECTION C. DESIGN INPUT
• SECTION D. DESIGN OUTPUT
• SECTION E. DESIGN REVIEW
• SECTION F. DESIGN VERIFICATION
• SECTION G. DESIGN VALIDATION
• SECTION H. DESIGN TRANSFER
• SECTION I. DESIGN CHANGES
• SECTION J. DESIGN HISTORY FILE (DHF)

HI All,

While reading through the FDA Design Control Guidance pdf, I came across this section,

Can someone answer the following two Q's?

The quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device. This raises two fundamental issues for developers:

What constitutes design output?

Are the form and content of the design output suitable?

@ppp23: if you are asking about what it is, it stated on that document that "Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record."
I don't fully understand the 2nd questions, could you elaborate a bit more?
(Please tag me in your reply)

Above, a lot of people listed all the requirements but I wanted to elaborate on one. I think the FDA looks to see that the design changes were implemented. This might seem trivial but its something to look for because people actually overlook this. They might have identified a problem earlier and there is documentation for that. They might have also suggested a solution. The FDA wants to make sure you actually implemented those design changes and updated the system to reflect the current standards. These standards change all the time and they are looking to make sure that recent developments were actually put into the product. A lot of people start a project and they get on one course and they never actually realize that the design control steps never really finish. You are never really done because you have to go back to planning or inputs whenever something happens in industry. This is where a lot of people end up making mistakes and this is what the FDA is looking for in a complete design control system. They are looking to see that you actually went over the design controls a few times and took everything into account.

In learning more on the FDA website about design controls, I found the International Medical Device Regulators Forum, which is a global approach to monitoring the manufacturing of medical devices in order to improve their safety and oversight at an international level. They have developed specific documents for advancing a Medical Device Single Audit Program (MDASAP). As stated on the FDA website- the MDSAP allows an MDSAP recognized Auditing Organization “to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program;

International participants include:
Therapeutics Goods Administration of Australia
Brazil’s Agencia Nacional de Vigilancia Sanitaria
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Device Agency
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the EU are Official Observers

From Jan 2014-Dec2016 FDA and International partners participated in the MDSAP pilot. In June 2017 they determined that the MDSAP pilot had “satisfactorily demonstrated the viability of the MDSAP” Overall it will be interesting to see how this MDSAP audit reports will substitute routine agency inspections.
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/