FDA GMP Quality System Regulation

Packaging and Labeling Control

Information & Training. | Medical Devices   >>>


What must be labeled?

Labels will be applied to containers, equipment, rooms, the product, stages of production, or may indicate cleanliness status, “under maintenance”, “out of order” etc..

The information appearing on labels should be clear, easily readable and not leave any confusion.


Label Integrity

All labels must 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.


Receipt and inspection

Upon receipt, all packaging and labeling materials, including pre-printed containers, inserts, and pre-printed packaging materials must be examined and acceptance activities performed to assure conformance with specifications. Also, samples of labels must be proofread by a designated individual(s). After being accepted by a responsible individual, these components may be placed into inventory or into production. These acceptance activities must be recorded in the device history record to show that inspection and proofreading were performed.


Area Separation and Inspection

All labeling and packaging operations should be separated to the degree necessary to make certain there are no mix-ups between similar products or labels. Separation may be either a physical or spatial separation or by performing the labeling and packaging at different times.



All printed packaging and labeling materials, including pre-printed containers, inserts and pre-printed packaging materials, must be stored in an area and manner suitable to prevent mix-ups.


Label Check and Record

When issued for use, labeling must be carefully examined to make certain the contents of the labeling comply with the labeling specifications in the device master record for the specific device being produced. This examination must include any control numbers or expiration dates used on the labels.



Labeling is part of the device master record; therefore, all changes to labeling must be made under a formal change control system.


Relabeling and Over-labeling

Over-labeling by placing a new label over an old label is discouraged by FDA but is acceptable as long as the new label and its use meet GMP requirements for attachment, legibility, reprocessing, and change control.


Control Number

Devices intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user require a control number on each unit, lot, or batch of finished devices and where appropriate for critical components to ensure traceability.


Sterile Device Labeling Control

Some devices are intended to be sterilized by the user before use. In this situation, the labeling should provide adequate information on at least one suitable method of sterilization and any precautions or safeguards to be followed.

For example, the labeling should describe any:

– special cleaning methods required;

– changes in the physical characteristics of the device that may result from reprocessing which affect its safety, effectiveness, or performance; and

– limit on the number of times re-sterilization and reuse can be done without affecting the safety or effectiveness of the device.


In the case of single-use sterile devices, labeling should advise against re-sterilization and reuse.


Information & Training.

Medical Device:

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
      • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
      • EU Medical Device Regulation and Classification (per MDD’s).
      • New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
      • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
      • Quality System requirements to maintain compliant Validations.
      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
      • Medical Device Software Validation.
      • Medical Device Design Validation.
      • Electronic Signature, Electronic Records.
      • Life Cycle Approach to Validation.
      • Risk Identification. Documentation. DHR’s. DMR’s.
      • Etc. Etc. …
      • Information & Training presentation >>>