The Medical Device Labelling Process Needs to Start Early in Design Controls

Mislabeled, misbranded medical devices are one of the top three causes for recalls in the U.S.

I started writing articles about these recalls in the 1980s and, believe it or not, during the 30+ years, this same statistic has barely budged off of this FDA measurement. Here we are in early 2018 and yet again, medical device companies are still making labelling mistakes. One would think that our compulsory relationships with computer software (our friend) would assist this effort. 

Unfortunately, this is not the case.

Today, when companies make labelling errors it results in a “wildfire” because our friend spreads the mistake quickly in the wrong directions—sometimes without the humans even knowing it! Admittedly, many of the labelling issues occur because of errors produced during the manufacturing phases after product development and then into distribution. Mistakes can include, but are not limited to, the following: wrong lot number; wrong label on an immediate container; smudged print; failed adhesive; incorrect product name; typographical errors; wrong product in the rightpackage and vice versa; non-sterile product in a package that indicates “sterile.”

On the flip side, some issues concerned with labels and labelling can also stem from design controls. Where is our friend when we need support?  

When considering preventive measures, robust design controls are a major advantage if handled properly. First, let’s establish some definitions and regulatory positions before we discuss labels and labelling in a more prevention-based mindset. Yes, there are steps you can take to minimize mislabeling and misbranding of medical devices. It comes down to being in control.

Definitions and Regulatory Positions: The Federal Food, Drug and Cosmetic Act (FD&C Act) is the law under which FDA takes action against regulated products. Specifically:

Section 201(k) defines “label” as a:

  • “Display of written, printed or graphic matter upon the immediate container of any article, e.g. a medical device”

Section 201(m) defines “labeling” as “All labels and other written, printed or graphic matter:

  • Upon any article or any of its containers or wrappers, or
  • Accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.”

The term “accompanying” is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, videos, fillers, etc. “Accompanying” also includes labeling that is brought together with the device after shipment or delivery in interstate commerce. The larger concept word “labelling” is defined as basically everything you say and, in some cases, don’t say.

According to both FDA and an appellate court decision, “Most, if not all advertising, is labeling. The term ‘labeling’ is defined in the FD&C Act as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising.”

The first place that we see labels and labelling in design controls, in a formal and documented manner, is when we define and produce final design, or essential, outputs. “Officially” is the operative word in that we talk about labels and labeling during concept and feasibility research, but that usually presents itself in terms of unofficial conversation and possibly what the competition is saying about a similar product.Labels and labelling become part of the Design History File (DHF) and eventually part of the Device Master Record (DMR).

Labels are considered components and should be handled in accordance with 21 CFR Part 820.120.

Regarding misbranding, Section 502 of the FD&C Act contains the misbranding provisions for drugs and devices. It states that a device is misbranded under a number of different circumstances, including: 

  • Its labeling is false or misleading, 
  • Its packaging does not bear a label containing the name and place of business of the manufacturer, packer or distributor, and an accurate statement of the quantity of contents, 
  • Words, statements or other required information are not prominent on the labeling or are not stated clearly, 
  • It is intended for human use, 
  • Its label does not contain adequate directions for use.

Design Considerations for Labels and Labelling

The goals for the design of labelling during product development are to inform the end user of pertinent information—so that there is understanding and comprehension—and to avoid mislabeling and misbranding issues later on in the lifecycle of the medical device and process controls.

Adequate labeling for a medical device requires proper design and procurement of the labels and labeling from an approved supplier. Design includes generating the content of labels and labeling and making sure it meets FDA requirements, as well as end-user needs. Several concepts must be considered to achieve these goals, including writing to the reader, referring to the actual device in labeling, obvious identification of the controls used, etc. Design controls for label integrity are imperative for compliance.  

Various sections of the Quality System (QS) Regulation have an impact on labeling including: section 820.30, Design controls; section 820.80, Receiving, in-process and finished device acceptance; and section 820.70(f), Production and Process controls, which requires buildings to be of suitable design and have sufficient space for packaging and labeling operations. 

Section 820.120 deals with specific requirements for device labeling. These sections apply controls to labeling content to meet the patient and user needs, as well as to meet the labeling specifications contained in the DMR. Applying the regulations to the physical design applications of labeling assures legibility under normal conditions of use over the expected life of the device. It also helps to assure the proper inspection, handling, storage and distribution of labeling. 

The requirements in 820.30(c), Design input, address intended use of the device and patient and user needs. When designing a regulatory strategy, start early in the lifecycle of the development of the device. The concept and feasibility stage is not too early. These conversations eventually become design inputs leading to labelling outputs familiar in the DMR. This regulatory strategy depends upon clear and accurate indications for use, knowing the intended use of the device and, of course, substantiated labelling claims from sales and marketing personnel.  

Additionally, this initial strategy should deal with possible product liability issues and postmarket surveillance data gleaned from similar medical devices. Because risk is always considered a design input, this approach to label and labelling development enables the regulatory and design teams to formalize an issued and dynamic risk assessment document. If your device is subject to a formal submission to FDA, such as a premarket notification or premarket approval, having the labelling completed prior to the pre-submission meetings held with FDA is imperative. This, of course, can occur during research and concept feasibility. Labelling should also be part of the agenda during these pre-submission meeting(s).

Label Integrity

Section 820.120(a) states that, “All labels shall be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage and use.” Likewise, other labeling such as user instructions should remain legible during customary storage and use. Labels may be mounted by adhesives, screws, rivets, drive screws, etc., or printed or etched onto panels or onto controls. The labels should be properly located so that they will be clearly seen and read.

Approval Policy and Procedure

The review of labeling, from the design stage through the finished device cycle, should be documented just like the review of other significant, high-risk components. This includes labeling development, any proposed changes and final approval. Documentation should be included in the design history file of the procedures used, signature of the responsible person and date. Before release for use, labeling should be reviewed and approved by product development, service, marketing, quality assurance, regulatory, clinical and other appropriate individuals. Your company must have a policy/procedure which covers the drafting, review and approval of labeling. 

Design Transfer

Specifications are required in the DMR for the content and physical design parameters of labels. Hardcopy labels, package inserts and similar labeling are also specified and purchased as components. For correct purchase and use of labeling, specifications are usually stated on engineering drawings and/or purchase specifications. Thus, artwork or “copy” alone will not fulfill the DMR and purchasing control requirements for labeling, except for the most simplistic labeling. The engineering drawings or purchase specifications should specify, as appropriate, the label substrate, dimensions, ink, finish, mounting method, etc., so that the purchased label will remain attached and legible during the customary conditions of processing, storage, handling, distribution and use.

Suggested Process Control Points during the Life Cycle of Label Development—Preventive Action  

Remember that design controls not only pertain to the design of the final device, but also the design of the processes used to develop, manufacture, store and distribute it. The following control points are developed during the design phase and then transferred to manufacturing and quality assurance:

  • Design Controls: Design meets the needs of user and intended use. Text review is important and should be well documented. Establish the quality of mounting of the labelling such as rivets, adhesives, etc. The quality of ink, paper or media should start as a design input.  
  • Verification/Validation: Conduct simulated or actual processing such as sterilization, shipping tests, label affixing, etc.  
  • Making Labelling Changes: Establish and maintain approval procedures and resulting objective evidence.
  • Proper Documentation: Approve, date and change control label drawings with the proper authority. A key label shall contain the control number either on the finished device or accompanying device. The engineering drawings or purchase specifications and mounting procedure must specify, as appropriate, the label substrate, dimensions, ink, finish, mounting method, etc., so that the purchased label will remain attached and legible during the customary conditions of processing, storage, handling, distribution and use.
  • Procurement: Proofread before release to inventory stock. You must then record the signature of proofreader, functional position and date. Any manufactured labels must only come from approved suppliers.
  • Storage: Store labels to prevent mix-ups. Restrict access to only authorized personnel. Separate multiple operations to prevent mix-ups.
  • Area Inspection: Before beginning labeling operations, a designee must inspect the area and remove extraneous devices and labels. Document this activity in the DHR.
  • Issuing Labels and Labelling: Examine for identity and, where appropriate, expiration date and control number. Record the date and person examining labels.
  • File Sample: At least one actual primary identification label should be in the DHR.
  • Inspection Verification: Inspect the finished device, including labels and labelling, per written procedure. A designee must check all acceptance records and test results and see that requirements are met and records are complete.
  • DHF is the Basis for DMR: Whether your company considers a software-driven display to be labeling or data makes little difference under the QS Regulation. Either way, the finished device labeling or data must meet the DMR specifications throughout commercialization.

Storage of Labels and Labelling

Where feasible, labels for similar devices should be designed with different shapes and colors to reduce the probability of mix-ups. Thereafter, all printed packaging and labeling materials, including preprinted containers, inserts and packaging materials, shall be stored in an area and manner suitable to prevent mix-ups [820.120(c)]. Labeling should be identified and segregated to the degree necessary to prevent mixing of similar labeling. Access to labeling should be limited to authorized personnel.

Storage control should be appropriate for the number and kind of devices. For example, if your company has only one product with one label, it should not need an elaborately controlled storage area. On the other hand, a manufacturer with only few types of devices having dissimilar labeling would normally require more stringent control. This type of process control would be initially documented as part of risk analysis during design.

One case that requires dedicated attention to storage and control is pre-labeled “sterile” but not-yet-sterilized devices. Your company should make absolutely certain that mix-ups do not occur. Also, marketing personnel should be cognizant of labeling control requirements and the consequences of a violation while handing out samples. Most manufacturers of higher-risk sterile and non-sterile devices voluntarily use lot or serial numbers for production control and, if the need arises, to expedite failure investigations, repairs, modifications or recalls. Lot, batch or other control numbers are required for compliance.


When reviewing or auditing labeling operations, it is advisable to keep in mind that the QS Regulation contains interpretive requirements and therefore allows flexibility in a quality assurance process. The degree of labeling control needed to satisfy the QS Regulation varies considerably for different devices and operations. The level of control needed should be reconsidered when products are added or changed. Likewise, the controls needed and success of the existing control program must be reviewed during QS Audits. FDA spends quite a bit of time in this area during inspections.

Design Transfer (of labels and labelling)

Design transfer is an essential process in the early life of a product’s labels and labelling. It must be well implemented, especially for high-risk medical devices. The transfer process must be a part of the design plan. It is not uncommon for the designed labelling to be transferred in phases. Production specifications typically consist of written documents such as assembly drawings, inspection and test specifications and manufacturing instructions. They can also consist of electronic records, labels and labelling and packaging specifications.At high levels, FDA’s QS Regulation requires your company to complete the following steps in order to fittingly complete the design transfer process:

  • Establish and maintain procedures to ensure that device design—its components and processes—is correctly translated into production specifications and can “walk across the bridge” with authority and formality.
  • Transfer the product and process design into production methods and procedures.
  • Create a production and quality system environment that ensures the product and processes comply with regulatory requirements and industry standards.

The transfer of a product design into a manufacturing environment requires a comprehensive set of processes to coordinate multiple tasks simultaneously. This is the true challenge realized in the transfer process. Juggling many aspects of development in a compliant and efficient manner and then develop a recipe for success, i.e. the DMR. Experience, well-executed procedures and careful review are the keys to a successful transition. 

This is especially true when a product design is transferred to an outsourced manufacturer because of the greater potential for miscommunication. Differences in corporate cultures, business styles, quality systems and perceptions of what constitutes design transfer can contribute to political and logistical problems.

Recall and Conclusions

From my own research and review of FDA’s recall database, I have determined the following: 1) Over half of recalls over the past three years were attributed to packaging and labelling issues, 2) Less than 8% of recalls over this same period of time are attributable to the fault of the device itself and 3) Issues with device design have accounted for nearly 35% of all recall root causes determined. 

Included in this analysis are root causes determined to be directly correlated to subcategories of device design, such as component, labeling, packaging, process and software. When a recall is necessary, send two complete sets of labeling to your local FDA District Recall Coordinator. This documented emphasis should at least include: 1) Product labeling, including all private labels, 2) Individual package labels, 3) Case labels, 4) Package inserts, 5) Directions for use and 6) Promotional material (if applicable).

FDA believes that the degree of detail required for the control of labels and labelling is necessary because these same requirements have been in place since 1978, yet numerous recalls every year are the result of labeling errors or mix-ups. Therefore, more, not less, control is necessary. 

Maybe our friend can be of assistance?

John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC