No need for a DHF *

* If among most US Class 1 devices, and/or the Class 2 or 3 device was developed prior to 1996-7, and no device changes made since. 

I was recently contacted by a client who was in the middle of an FDA inspection.  The Inspector was questioning why one of their product's lacked a DHF (Design History File, 21 CFR 820.30; Design and Development File, ISO 13485 7.3).  I had previously inspected that company and found no problems, and had in fact done some of their current and "retroactive" (for missing) DHFs.  I had also done some 510(k)s for them, and as part of such a project, I also did the associated DHFs, since the 510(k) draws much of its information from documentation identical to and/or contained within or referenced in the DHF. 

After the initial, typical "panic" reaction to a possible 483 observation of an area of the company we were justifiably proud of (and I had previously inspected) passed, we checked their records and verified that the product in question was developed prior to 1996-7, as proven by their 510(k) for it, and that there were no changes to it since (based on visual checks, 510(k) and current documentation comparisons, and change history data reviews; it was a needle). They did have a Device Risk Management File (per ISO 14971) for that family of products that also covered it, so that was not an inspection issue.

The Inspector took this additional information back to their office and supervisor, and then later indicated that the FDA agreed with our rationale and would not be writing a 483 observation for that issue. 

Two previous FDA inspections had never raised this issue. 

I recommended the client  add a "Memo to File" / "one page DHF" to their DHF files for this product (and any similar older, "grandfathered", unchanged product), detailing the above points, to eliminate any similar questions / challenges during future inspections. 

I also mentioned that while they were compiling such a "Memo to File / DHF", if additional provable / documented information was available that pertained to that product's development, it could certainly be so noted and included in the "Memo / DHF", for future reference and/or company IP purposes.
 

See also my blog post on "DHF's ...", dated 10/09/2017, below. 

Note:  Even for older, pre-1996-7 developed devices, I encourage companies to develop a retroactive DHF, to the degree possible, to capture available development history before it disappears due to employee turnover, retirements, deaths, etc., for IP purposes, assist in Root Cause Analysis, training, line extensions / product improvement, future 510(k)s, and similar.   

-- jel@jelincoln.com