In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.184 (Device History Record).
Similar to the previous edition of DG, the doctor’s guidance on the Device Master Record (DMR), the Device History Record (DHR) is another collection of documents the agency will review during one of their friendly visits. The DHR is a collection of activities such as production routers, as-built configurations, test and inspection results, copies of labeling, etc., retained for a specific device or batch of devices. In short, the DHR is reflective of all work activities completed during the manufacturing process. As part of the final acceptance activities, the DHR will be reviewed for completeness, accuracy, and retained as evidence of compliance to the QSR and the DMR.
Just a quick note from Dr. D in regards to expectations; the doctor has never experienced an inspection from the agency, where a significant amount of time was not spent on the review of DHRs. Device manufacturers can take it to the proverbial bank: DHRs will be scrutinized during the punctilios (look-it-up) of a routine QSIT inspection.
Warning letter violations
In this first warning letter, the offending device manufacturer has failed to include all records associated with the manufactured device into the DHR. Besides, being the recipient of a 10-observation warning letter (duh duh-duh!), they failed to incorporate packaging and labeling steps into the DHR. Remember, packaging and labeling are key operations incorporated into the manufacturing process. In fact, the part numbers and lot numbers associated with the packaging and labeling operations need to be captured in the DHR. Typically, the packaging and labeling steps are embedded in the production routers. Additionally, a copy of the actual printed label and DFU, packaged with the product, should be retained in the DHR.
Furthermore, when responding to a warning letter or Form 483 observation, specifically when the correction will be resolved by modifying a document or work instruction, manufacturers need to send a copy of the actual change to the agency. Why? Because without documented evidence, the event did not occur, or in this case, the change was never made.
As for the second warning-letter recipient, this manufacturer has become one of the doctor’s favorite offending device manufacturers. As Dr. D has stated on multiple occasions, this manufacturer was awarded with a 19-obervation warning letter, with a few dozen subparts. Once again, fitting for a ‘Duh, Duh-Duh,’ my favorite tag line from Carlos Mencia. Once again, “Failure to establish and maintain procedures,” is a prevalent theme. Keep in mind, if the device sold is categorized as software, and the software is being distributed, a DHR is required. Additionally, the product shall be labeled and a copy of the labeling retained in the DHR. Furthermore, all changes need to be captured. Finally, because Dr. D is always impressed with a device manufacturer that has managed to collect a 19-observation warning letter, the doctor is compelled to shout out an additional “Duh, Duh-Duh.”
Warning letter One (September 2010): Observation 7 of 10 – The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820. Specifically, your device history records for the ME dryers do not include records of the packaging or labeling of the devices as required by 21 CFR 820.184. Packaging and labeling are part of the manufacturing process and all dates of these activities need to be recorded. Furthermore, a copy of the device label, including lot number, must be kept in the device history record.
FDA Response to Observation 7 of 10 – Your response states that the “ME Packaging Overview” document will be revised. We cannot make any assessment regarding the corrective actions because no revised document was submitted.
Warning Letter Two (March 2010): Observation 15 of 19 – Failure to establish and maintain procedures to ensure that device history records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of 21 CFR Part 820, as required by 21 CFR 810.184. For example:
a. When requested, no DHR for the research, research-waterload or the waterload software Version (b)(4) tested and distributed to customers was provided.
b. There is no record of device labeling.
c. Changes to the software are not documented in the Design History File and are not tracked and/or verified. There is no documentation listing the number and/or type of changes that were made.
Quality System Regulation – 21 CFR, Part 820
QSR – Subpart M – Records
Section 820.184 Device History Record
Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.
Device history record
As with all elements of the QSR, the basic requirement will typically begin with the phrase; “Each manufacturer shall establish and maintain procedures.” Right out of the starting gate FDA is clearly dictating that procedures are required, as in DG rule # 6, – All procedures, work instructions, drawings, specifications, etc. must be written, well-documented, and controlled within a defined document control system. Through the QSR, the DHR is linked backed to the DMR.
For example, the DHR is the receptacle of document evidence that each manufactured device, batch, or lot of devices has been manufactured in accordance with the DMR. Additionally, the QSR provides sufficient granularity in regards to DHR content and the providing of pointers for specific pieces of information. As a minimum, the DHR shall include:
1. The actual date a device, batch, or lot was manufactured;
2. The actual quantity of devices manufactured;
3. The actual quantity of devices accepted and entered into distribution;
4. All of the records, inspection results, test results, evidence of sterilization, and other quality and manufacturing records that support devices being manufactured in accordance with the DMR;
5. A copy of the actual product label (pouch and carton) and the Directions for Use (DFU); and
6. Any additional identification, serial, or control numbers employed.
Remember, a good rule of thumb is to ensure all documentation relating to the actual manufacturing of a finished medical device shall be retained in the DHR. The DHR is the documented evidence needed, by device manufacturers, to support compliance to the QSR. Why? Because documented evidence is always a device manufacturer’s best defense during an FDA inspection.
Takeaways: Complete DHR a fundamental requirement
This week’s guidance was pretty straightforward. The DHR contains a number of records that support a device manufacturer’s claim that a medical device was manufactured in accordance with the DMR. A DHR containing complete and accurate information is a fundamental requirement needed to support claims of compliance to the QSR during a friendly visit by FDA. Finally, a complete and accurate DHR will be a valuable asset should devices need to be recovered due to a RECALL. (Darn it Dr. D, you had to ruin the paper with mention of that nasty six-letter word!)
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG, when I begin providing guidance for Subpart – M (Records), specifically 820.186 (Quality System Record) – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2009, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- FDA – U.S. Food and Drug Administration Website. (2010). Warning letters. Retrieved October 5, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/