FDA Labeling and Instructions for Use – Medical Devices
20 Aug 2024
Under the FDA, the Quality System regulations have requirements regarding Good Manufacturing Practice (GMP). To meet these requirements, medical device manufacturers should incorporate various elements in their Quality Assurance (QA) systems. The QA program should ensure manufacturers meet the GMP device master requirements. They should also ensure that the labeling operations remain controlled, as this will allow correct issuance and use of the labels.
What is Included in Labeling?
Labeling includes:
- Control labels
- Directions for use
- Equipment labels
- Package labels, and
- Maintenance manuals, etc.
Labeling on CRT and Message Panels
Displays on CRT and/or electronic message panels are also considered as labeling if cautions, instructions, prompts, and parameter identification information are given on them.
QS Sections and their Impact on Labeling
There are various QS regulations that impact labeling. These are:
- Section 21 CFR 820.80 (b) requires incoming materials to be inspected and tested. This also includes labeling.
- Section 21 CFR 820.70 (f) requires buildings to have sufficient space and suitable design to conduct their packaging and labeling operations.
- 21 CFR 820.120 presents specific requirements for labeling control.
- This section applies to the application of labeling and ensures legibility within normal conditions of use over the device’s expected life.
- Requirements of this section also apply to inspection, handling, storage, and distribution of labeling.
If these requirements are not fulfilled, then the FDA will consider such devices as adulterated. These devices will also be adulterated if they do not comply with GMP requirements, such as change control and proofreading. However, it is important to know that these requirements are not applicable to the labeling content’s adequacy, except for ensuring that the content complies with labeling specifications present in the device master-record.
Specifications in the Device History File (DHF)
21 CFR 820.30 requires specifications to be present in the Device History File (DHF) for the physical design and content parameters of labels. Here, labeling specifications include:
- Artwork and/or engineering drawing for each medical device label
- Control procedures and inspection, and
- Procedures to attach the labels
Every procedure, artwork, and drawing must bear the preparer’s name, approval signature, and date. The approval signature and date can be present on a label approval form or the backside of the artwork.
Artwork Requirements Essentials
If the “content” of the artwork is duplicated on approved engineering drawing (or if it is adequately identified/cross-referenced regarding the label approval form),then artwork can also contain only an identification code or title. Package inserts, hard copy labels, and other similar labeling are specified and purchased as components. For the correct use and purchase of labeling, specifications are listed on purchase specifications or listed drawings. In this scenario, the artwork or “copy” alone won’t fulfill the device master record requirements for labeling (except for the most simplistic labeling, e.g. brief errata sheets).
Specific Labeling Requirements
Label Integrity
The labels must be designed and applied to devices and containers such that the labels remain in place and stay legible during their distribution, storage, and use. Similarly, other labeling, such as user instructions, must remain legible, especially during customary storage and use.
For example, labeling that is printed onto plastic in in vitro diagnostic media plates via machines can get smeared sometimes which renders it inadequate. Thus, the manufacturers of such devices should ensure that their print is legible and remains legible until their use.
Receipt and Inspection
After receipt, every packaging and labeling material, including preprinted packaging materials, preprinted containers, and inserts, must be examined. Acceptance activities must be performed on them to ensure their conformance with the specifications. Designated individual(s) should also give these samples a read.
Once a responsible individual accepts them, these components can be placed into the production or an inventory. Acceptance activities must be recorded into the device history record according to 21 CFR 820.80(e) and 21 CFR 820.120. This will prove that the inspection and proofreading activities have been performed. Acceptance record should be kept simple for device labeling.
Area Inspection and Separation
All the labeling and packaging operations should be separated such that similar products and labels do not get mixed up. This separation can be
- Physical,
- Spatial, or
- Done by performing labeling and packaging at different times for different activities
Requirements Regarding Unused Labels
Unused labeling of products, such as pre-coded serial numbers, expiration date, manufacturing date, and control numbers, should be destroyed and not returned to the storage area.
Storage Labels
All the printed packaging and labeling materials, including inserts, preprinted containers, and preprinted packaging materials, must be stored in an area suitable enough to prevent mixups. Labeling must be identified and segregated such that any mixups of similar labeling are prevented. Access to labeling must be limited to allowing personnel only.
Label Check and Records
After being issued, the labeling must be examined to ensure the contents comply with the labeling specifications in the device master record. The examination must have any control numbers or expiration dates to be used on the labels. Furthermore, this issuance check must be recorded, including the name of the person who performed the examination (and the date on which it was performed).
What are the IFU Requirements Under the FDA?
The IFU requirements under the FDA guide manufacturers into making patient-friendly labels that accompany medical devices and prescription drugs. One of the key requirements of IFU is to write them in a detailed and step-by-step manner, such that every requirement regarding preparation, administration, handling, storage, and disposal is completely clear. Furthermore, visuals must be present to accompany the instructions.
Managing Requirements for Labeling and IFUs
We know that to prevent your device from being labeled as adulterated; comply with all the FDA’s requirements regarding IFUs and labeling. With impeccable expertise in this field, we are determined to provide our consultation services to you regarding the fulfillment of IFU requirements. Our regulatory experts and consultants will ensure that all your labeling requirements, whether major or minor, get fulfilled with ease. To learn more, inquire us today!
