FDA Device History File vs. EU Medical Devices Directive Technical Files

The FDA has built the DHF around control. This is the defining factor. It has designed GMPs around this. For the FDA, the DHF shows design output as a product of design input. It traces the device’s development history, and how design requirements were met in accordance with 21CFR 820.

FDA DHF shows design history between research and development, something of a grey, overlapping area. Now, if a company decides to commercialize a product that it was earlier researching; or if some other change happens to the product, that is from when design control takes over. Design Controls also demand that the principles of design control are met and that the product is under change control. In other words, it shows a sequence of events over a period of time.

For the FDA, DHFshould be proven by the design history. US FDA Design Control Documents include

o   design planning

o   design input

o   design changes

o   design reviews

o   design verification/validation

o   design transfer –all of these have to be demonstrated in the DHF.

This is in contrast to the parameters set out in the EU’s Medical Device Directive (MDD), whose technical file shows conformance with that device’s “essential requirements”. The EU Council Directive 93/42/EEC (Medical Device Directive), in its Annex VII, EC Declaration of Conformity, has clear guidelines on conformity on the part of the manufacturer. It states that the technical documentation must include:

o   a general description

o   design drawings, diagrams/descriptions

o   methods of manufacture

o   risk analysis results

o   essential requirements/standards met

o   methods of sterilization, where applicable

o   results of design verifications/validations/test results

o   labels/instructions for use.

As a reading of these points suggests, the emphasis is on different aspects of documentation between the two systems.

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