In today’s blog, we will explore about US FDA Labeling Requirements. Whether you’re a startup or established manufacturer, understanding the US FDA Labeling Requirements is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about US FDA Labeling Requirements

Let’s get into the topic.

US FDA Labeling Requirements

General US FDA Labeling Requirements

In US FDA, General labeling requirements for medical devices are specified in 21 CFR 801. These general labeling requirements are minimum requirements to be followed for all medical devices.

21 CFR 801 is further classified as follows.

21 CFR 801.1 – Name and Place of Business

21 CFR 801.4 – Intended Use

21 CFR 801.5 – Adequate Directions

21 CFR 801.6 – False or Misleading Statements

Let’s discuss in detail each of the above general labeling requirements.

21 CFR 801.1 – Name and Place of Business

Medical device labels shall contain information about the name and place of business of medical device manufacturer, packer or distributor. Street address, city, state and Zip code information shall also be provided.

21 CFR 801.4 – Intended Use

If the medical device is intended to be used for conditions or purposes other than which it was intended, the manufacturer of medical device shall provide adequate information in labeling in accordance with new intended use.

If the medical device packer, distributor or seller intends to use the medical device for conditions or purposes other than which it was intended, they shall provide adequate information in labeling in accordance with new intended use.

21 CFR 801.5 – Adequate Directions

Adequate directions for use shall be provided in the medical device labels. Adequate directions for use by which a layman can use the medical device safely for the intended purpose.

21 CFR 801.6 – False or Misleading Statements

If a medical device makes false or misleading statement with respect to other medical device, drug, cosmetic or food, such medical device is considered as misbranded.

US FDA Quality System Regulation Labeling Regulation

Label Integrity

All the labels used in medical devices must be designed and applied on to the medical device in a manner that the labels will remain in place and legible during the distribution, storage and use.

Receipt and inspection

Upon receipt, all packaging and labeling materials including preprinted packaging materials, inserts must be inspected to ensure that the materials are in conformance with specification. Also, proofreading of label samples by designated individuals must be performed. After the acceptance of proof reading by the designated individual, the labels can be placed into production or inventory.

Area Separation and Inspection

There shall be no mix-ups between similar products or labels. All packaging and labeling operations shall be separated to ensure that there are no mix-ups. Separation of operations can be spatial or physical or different time zones can be preferred for performing labeling and packaging of different devices.

When label mix-ups are impossible, separation is not required. Stringency of production controls can be based on the likelihood of labeling mix-ups.

Storage

All packaging and labeling materials, including preprinted packaging materials must be stored in a manner to prevent label mix-ups. Labeling should be segregated and identified to prevent mix-ups with similar labels.

Label Check and Record

All labeling must be inspected when issued for use, to ensure that the contents of labels are in conformance with specifications in device master record. The control numbers and expiration dates on the labels must be examined.

If there are no chances of label mix-ups, the initial inspection performed when the labels are placed in inventory is sufficient to ensure conformance with specification in device master record.

Changes

Any changes to the labels must be executed under a change control system like the execution of specification changes. When there are any changes to medical devices or its primary documentations, its secondary impact on labeling must be assessed. There should be a section in change order forms to assess the impact on labels.

Relabeling and over-labeling

Placing a new label over an old label is called over-labeling and it’s discouraged by FDA. However, its is acceptable as long as the new label meets the above GMP requirements for legibility, change control, reprocessing & attachments.

Now I hope you have acquired some basic knowledge about the US FDA Labeling Requirements. We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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