Talk:Design controls

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I'd like to rewrite this whole article, as IMHO it is wrongly focused on the FDA requirement. "Design control" is a practice by itself. Such practice is recommended and/or required by MANY OTHER regulatory bodies than the FDA, through many other regulations and/or standards than the CFR listed here (e.g. ISO13485 or 9001), and in MANY OTHER fields than medical devices (e.g. defense, pharma, nuclear energy etc...) [edit] : done

Also, "The objective of Design Controls is to demonstrate compliance to the various "tests" imposed by the Code which would then suggest a minimal, but acceptable, level of medical device efficacy and safety." is totally wrong. I reworded this whole sentence. --MarmotteiNoZ 01:48, 23 November 2010 (UTC)

Proposal: I propose editing the bullet list which describes the elements of design controls from the FDA regulations to more fully match the 10 specifics in those regulations. In addition, I'd add the corresponding elements, which align quite well, from ISO13485/9001 and highlight the differences. One example of a difference is that FDA includes design transfer but there is nothing quite the same in ISO13485/9001.

I'd also strengthen the point that design controls apply to the development of new devices as well as changes to existing devices on the market. Design control is often viewed as something that applies only to R&D but it applies to the manufacturer who is responsible for the device, whether it is new to market or a revision. Drtom53 (talk) 21:28, 25 June 2014 (UTC)


I added more detail about medical devices as this is the context in which it is quite frequently cited, and indicted that it applies to ALL medical devices. Stopping well short of the plagiarization cited below, my intent was to summarize the core of FDA Design Controls in a way that makes this entry actually useful for someone wishing to learn more. I also reworded the last paragraph to take out absolute words like "guarantee" and "ensures" and instead characterized it as intent.

Also, I made some grammatical corrections by adding the missing word "development" to the initial sentence and deanthropomorphizing "manufacturers", added the specific reference to the MDD, and corrected the sentence about ISO 13485 being required.

Dmaltz (talk) 22:55, 24 January 2012 (UTC)

Thanks for the grammar fixes. Note though that design control is not required by FDA for all medical devices, only classes 2 and 3 + some but not all of class I... Otherwise, I delete again the copy/paste from FDA website. Note also that the detailed explanation of the "activities" as required by the FDA is already given in the DHF article which is linked from within this one, so there is really no need to repeat that.--MarmotteiNoZ 02:54, 2 April 2013 (UTC)


After checking the link, the whole article is actually a copy-paste from the CFR. Whereas I think the CFR is copyleft (US Federal regulation), it is agains WP policy so I deleted it all.--MarmotteiNoZ 01:59, 23 November 2010 (UTC)