Changes could be coming for medical device labeling regulations. On January 7, 2013, the Food and Drug Administration (“FDA”) announced in the Federal Register a public workshop and solicitation of comments concerning “Accessible Standardized Medical Device Labeling.” The Federal Register notice can be viewed here and the public workshop will be held on April 29 and 30, 2013. FDA is soliciting comments for the public workshop until April 12.
FDA’s goal of standardized labeling, not surprisingly, is to improve the effectiveness and safety of medical devices. The background section of the notice explains that “[c]urrently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling.” Medical devices are required to follow general labeling requirements in 21 C.F.R. Part 801, which does not contain standardized requirements like those for food and drug products that detail labeling from the layout of headings and subheadings to required language. See e.g., 21 C.F.R. 201.80 and 21 C.F.R. 201.56. FDA is concerned that there is “increased risk of medical device [user] error” due to the lack of device labeling standards.
FDA adds that the risk is increased due to the lack of access to device labeling – “there is no single available source of medical device labeling for people to view, search and download for devices.” As a result, FDA indicated that it will propose an online database to make available standardized device labeling, which may be similar to the National Institute of Health’s DailyMed website, a searchable site for package inserts for marketed drugs. Adding to safety concerns, FDA points to the growing responsibility of patients to operate medical devices “as more devices migrate out of clinical care environments and into patients’ homes.” An online database containing device labeling may assist patients that misplace or discard proper and necessary labeling.
FDA has done its research in this rulemaking process, conducting a two-phase study and a survey with healthcare professionals. The study, conducted with the Research Triangle Institute, focused on healthcare professionals’ experiences with medical device labeling, including what they would like to see in a standardized version of device labeling. The survey was given to members of the National Family Caregivers Association to draw from caregivers’ experiences with medical device labeling for devices used in the home environment. The notice states that “key findings from the survey [sic] helped create an outline for the standard content” for the labeling, and identify the most relevant sections. The study and survey indicated:
- A need for a condensed version of labeling to act as a quick reference for the safe and effective use of devices.
- Having a standard content and format for a “quick guide” would be more convenient and effective with the option of referring to a more comprehensive form of labeling.
- An interest in a hierarchy of labeling sections, based on importance, when operating or troubleshooting a device in the home care environment.
- An interest in the use of a searchable website that contains labeling for medical devices.
Per the Federal Register notice, the workshop will focus on the above topics and discuss standard content and formatting for device labeling, including a review of an outline of the draft standards and current thinking on standards.
This, no doubt, will not be an easy rule to pursue. As touched on in my blog post about FDA’s proposed rule for Unique Device Identification, regulations for medical devices are generally not easy to standardize due to the breadth of medical device products available. Should a manufacturer of medical gloves be held to the same standard of labeling as an implantable defibrillator firm? Many would say probably not. More than likely the standard will not be one uniform template for all devices, but rather multiple variations to be applied depending on the nature of the technology, the level of risk associated with the device, and other factors. The proposed outline for standardized labeling should be interesting, as well as the comments that will follow. If medical device labeling requirements are of concern to you, now is the time to start reviewing FDA’s plans and to make your views known so you can attempt to impact the process and direction of developments at an early stage.
