DHF Required for a Class I Device? At least 67%…

Is a DHF required appears to be a simple yes/no question? If you reword the question, however, you get a very different answer.

Is a DHF required DHF Required for a Class I Device? At least 67%...

If you ask, “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes, a DHF is required) of 100% (No DHF required), the answer is that you need 33% less documentation for the design of a Class 1 device.

The FDA shared a presentation on design controls in 2015.

In that presentation, the agency identified six Class 1 product classifications that require design controls, while thousands of Class 1 product classifications do not need design controls. Despite the lack of design controls, manufacturers must still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs), and design changes may still require revalidation before implementation.

Why is a DHF Required for Class 2, but Not for Class 1?

Class 1 devices are simple devices that are already on the market and have a history of clinical safety. Class 2 devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a higher risk for Class 2 devices. When you design a Class 1 device, you still have to determine what your design specifications will be. Again, you don’t need: 1) to review and approve design inputs, 2) a procedure to document your design process, 3) to document formal design reviews, and 4) to create a design plan.

In the 1997 guidance document for design controls, the FDA states that a design transfer procedure should include at least three basic elements:

  1. design and development procedures should consist of a qualitative assessment of the completeness and adequacy of the production specifications;
  2. procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved; and
  3. procedures should ensure that only approved specifications are used to manufacture production devices.

The first of these basic elements is not required for Class 1 devices because product specifications for most Class 1 devices are simple. The other two requirements are fundamental principles of document control and configuration management. Therefore, you still need a design transfer procedure for Class 1 devices, but you don’t need to include the first element that relies upon design and development procedures.

If you have a Class 1 device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you must still validate and re-validate the process in accordance with 21 CFR 820.75. Class 1 products also require a device master record (DMR) in accordance with 21 CFR 820.181.

What is Not DHF required?

Needed for Class I (67%)

  1. Approved Design Outputs
  2. Labeling Procedure
  3. Approved Labeling
  4. Sterilization Validation Procedure
  5. Sterilization Validation Protocol and Report
  6. Design Transfer Procedure
  7. Approved DMR
  8. Design Change Procedure

Needed for Class II and Class I requiring Design Controls (100%)

  1. Design Control Procedure
  2. Design Plan
  3. Approved Design Inputs
  4. Approved Design Outputs
  5. Labeling Procedure
  6. Approved Labeling
  7. Sterilization Validation Procedure
  8. Sterilization Validation Protocol and Report
  9. Design Transfer Procedure
  10. Evidence of at least 1 Design Review
  11. Approved DMR
  12. Design Change Procedure

Therefore, although you do not technically have to have a DHF for a Class 1 products, the difference between the two categories is the following elements:

  1. Design Control Procedure
  2. Design Plan
  3. Approved Design Inputs
  4. Evidence of at least 1 Design Review

When an FDA inspection occurs, the investigator will review your design control procedure and then audit your DHF in accordance with your design plan.

When you have a Class 1 device, you are not typically inspected unless there is a problem. When ORA inspectors perform an inspection for Class 1 devices, the inspector looks for evidence of items in the first list.

If you are interested in learning more about design history files (DHF), please check out our DHF webinar.

5 thoughts on “DHF Required for a Class I Device? At least 67%…”

    1. Thank you for the question Glenn. As I indicated in the blog you commented on, there are 4 items required for higher risk devices that are not required for a Class 1 device (exempt from design controls). Those items are: 1) a design control procedure, 2) a design plan, 3) approved design inputs, and 4) evidence of at least 1 design review. For software you are required to have a software quality system and the recognized standard for software devices is IEC 62304. Rather than the term “inputs” software devices require a software requirements specification (SRS). This is equivalent to design inputs. Class 1 devices would not require a design controls procedure, but their software quality system would more comprehensive than a design control procedure. Many software products skip the formal design plan, but instead they use a reiterative design process with sprints to rapidly develop the next iteration of the software and then test it. This is acceptable to the FDA, but you still need to document these activities, because they are part of software validation. Finally, you are not required to perform a design review. However, software development of medical devices requires identifying and documenting software bugs identified during validation. Before the final product is released the team must verify that each of the bugs is acceptable in the final release or the bug must be resolved prior to release.

  1. Hi Rob, do you have a source or section of FDA 820 that you are referencing for the requirements of Class 1 devices? The PowerPoint is clear about what a class 2 and 3 need to perform for design controls as well as the 6 specific class 1 devices but I was unable to find any comments about the requirements of the rest of class 1 devices. Thanks for the feedback!

    1. There are currently no design control requirements for the other Class 1 devices, but design controls would still be required under ISO 13485:2016. We are still not sure how the FDA’s adoption of ISO 13485:2016 later this year (2020) will impact this rule.

  2. Pingback: Risk Management Requirements - Medical Device Academy 510k vs DHF Medical Device Academy

Leave a Comment

Your email address will not be published. Required fields are marked *

Time limit is exhausted. Please reload the CAPTCHA.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Scroll to Top