FDA Medical Device Labeling requirements.

The U.S. Food and Drug Administration (FDA) develops and administers labeling regulations related to medical devices. The Labeling regulations relevant to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR).

General Device Labeling – 21 CFR Part 801
In Vitro Diagnostic Products – 21 CFR Part 809
Investigational Device Exemptions – 21 CFR Part 812
Good Manufacturing Practices – 21 CFR Part 820
General Electronic Products – 21 CFR Part 1010

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 >>>

The FDA under Section 201(k) defines a ‘label’ as a:

– ‘display of written, printed, or graphic matter upon the immediate container of any article…’

The term ‘immediate container’ does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear ‘on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.’

Section 201(m) defines ‘labelling’ as:

– ‘all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) 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, fillers, etc. ‘Accompanying’ also includes labelling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

Is Advertising a form of Labeling?

Most, if not all advertising, is labeling. The term ‘labeling’ is defined as including all printed matter accompanying any article.

Medical Device Related Labeling Topics

– Investigational Device Labeling Requirements
– Unique Device Identification
– Symbols in Labeling

General Labeling Guidance Documents

– Labeling – Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF – 3MB)
– Device Labeling Guidance #G91-1 (Blue Book Memo)
– Guidance on Medical Device Patient Labeling – Final Guidance for Industry and FDA Staff (PDF – 333KB)
– Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities – #G03-1
– November 2004 Medical Devices Technical Corrections Act (MDTCA) Expanded Authority for Electronic Labeling (PDF – 268KB)
– Alternative to Certain Prescription Device Labeling Requirements: Guidance for Industry (PDF – 22KB)

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 >>>