|Footnotes for this article are available at the end of this page.
Recently, a medical device company received a Warning Letter from FDA for a number of quality-related deficiencies, including issues with Medical Device Reporting (“MDR”), the promptness (or lack thereof) of handling and closing a Corrective and Preventive Action (“CAPA”), and an inadequate Health Hazard Analysis (“HHA”).1 Channeling Nine Inch Nails’ 1994 classic song, “Hurt,” the company hurt itself in numerous ways, and FDA focused on the pain that patients might endure because of the quality concerns.2
This Bulletin will not cover all of the deficiencies raised in the Warning Letter; we will focus only on those which we believe are particularly interesting and useful for industry to review.
- FDA expressed concern about the company’s HHA, where the company decided it did not need to take further action:
FDA does not agree that the risk to the patient is of a low enough risk to not warrant further action at this time. The HHA conducted does not discuss how/why the risk to the patient is not increased by exposure to the [product] during the procedure as it is removed. The HHA does not consider the risk of tissue injury . . . 3
- FDA raised objections to the company’s MDR process.
The agency noted it was unclear if the company evaluated devices shipped to other markets that might raise a similar concern or could possibly be imported into the U.S. by a third party, stating, “[Y]our firm did not mention a plan to train its personnel on these new procedures, nor did it clarify that the retrospective reviews that were done were in line with the new requirements of its procedures.”
- The MDR procedures did not establish internal systems that provided for timely and effective identification, communication, and evaluation of events that might be subject to MDR requirements.
The procedure included definitions for the terms “become aware,” “malfunction,” “MDR reportable event,” and “reasonably suggest,” but it did not include definitions of the terms “caused or contributed” and “serious injury.”
FDA said, “The exclusion of the definitions for those terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting.”
- FDA questioned the company’s CAPA and documentation and why the investigation into certain complaints did not occur for two years, while the internal procedure required an investigation within 30 days.
- What is worse — to have an Standard Operating Procedure (“SOP”) that is lacking in detail or not to follow the SOP at all? Neither is good. In the case of the MDR observation, the company’s lack of regulatory definitions did not help the company maximize compliance; with the CAPA deficiency, the company’s SOP specified a deadline to review, investigate, and close out a complaint (through a CAPA), but the firm failed to comply with its own internal procedure.
- It is important for a company’s HHA to consider worst-case and what-if scenarios. FDA expects more, rather than less, investigation and for a company to take appropriate corrective action to protect patient care.
- Any company documentation must be thorough and be able to stand on its own, without the reader (here, FDA) having to guess or interpret. Gaps of information or lack of detail may lead to FDA skepticism about a company’s investigative plan, which is never good. A question begets a question.
- To state the obvious, an FDA inspection is not fun. A poor inspection is really not fun and can be painful. Companies should maximize opportunities to minimize self-inflicted wounds through unforced errors, such as not following internal policies, conducting inadequate investigations, and not drafting SOPs with sufficient specificity.
- Companies should review FDA’s Warning Letters, which are posted online, to better understand the agency’s concerns. Nine Inch Nails’ song ends:
If I could start again
A million miles away
I would help myself
I would find a way
- We suspect that if the company that received the Warning Letter could “start again,” it would “find a way” to minimize the regulatory deficiencies.
 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corp-654013-03152023; the company received two other Warning Letters at different sites late last year.
 The authors are aware that Johnny Cash covered the song before his death.
 The company did not initiate corrective action and decided to monitor future complaints about the devices.