What are Design History File Requirements?

What are Design History File Requirements?

The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into the medical device manufacture worked in a preset process to arrive at the final product.

DHF requirements are an important component of the DHF. The DHF, a strict requirement from the FDA, is essentially meant to show conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is there to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. In other words, it eventually proves design control elements.

The US FDA states that DHF requirements need to be met. What are these requirements? The purpose of having specified DHF requirements is to ensure that user needs are met. It lists out a series of parameters that need to be met in order to ensure that these DHF requirements were met. These are:

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning
  • Design input
  • Design output
  • Design changes
  • Design review(s)
  • Design verification/validation
  • Design transfer
  • Design history file

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List of DHF requirements

List of DHF requirements

Which are the DHF requirements that the FDA looks for?

DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001.

It is meant to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. DHF requirements prove the efficacy and effectiveness of design control elements.

Details

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning –should relate the design and development plan –could ideally have Gantt Charts, reflecting changes whenever they are made
  • Design input –could explain requirements, Initial Product Performance specifications (marketing and engineering), and could include applicable standards, such as ISO or whichever
  • Design output: should consist of systems to evaluate design input requirements and should cover verification/inspection; QC and ensure proper functioning
  • Design changes –the FDA recognizes that any kind of change runs the risk of degrading the product; hence, the manufacturer should be on the lookout for possible snags
  • Design review(s), including by an independent reviewer, one who does not have a stake in the review process, should be prior to production. Should serve as milestones to take the product to the next level
  • Design verification/validation –the same as testing or inspection. It is basically meant to demonstrate that design output was a product of design input
  • Design transfer –involves transferring the R and D documents to design documents
  • Design history file, a complete documentation to demonstrate all of the above. This is the end result of all your design activities, proving that you got the process right.

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

Design History File content

Design History File content

The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product.

What is DHF?

It is defined, rather broadly, in ISO 13485 as being the record needed to provide evidence that the realization processes and the resulting product meet their specified requirements. 21 CFR 820.3 (e) of the FDA also describes DHF broadly as a compilation of records which describe the design history of the finished medical device.

Design history file content

Design history file content is described by both the FDA and ISO 13485.

Design history file content according to the FDA

  • General: A few Class I, Class II and Class III devices are listed here. These are the devices for which design controls apply
  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

ISO 13485

According to ISO 13485, design history file content should consist of the following rules:

  • The manufacturer shall establish plans thatdescribe the design and development activities
  • The plans shall identify and describe theinterfaces with different groups or activities thatprovide input to the design and developmentprocess
  • The plans shall be reviewed, updated and, andapproved as design evolves

References:

http://www.ece.mcmaster.ca/~patriciu/QSR.pdf

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30

Contact Detail

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Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801