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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Labeling

Copies of all proposed labeling for the device must be included in the PMA submission. The labeling must comply with the requirements in 21 CFR 801 (Labeling) or 21 CFR 809 (In Vitro Diagnostic Products for Human Use). That is, the label must include the common name of the device, quantity of contents, and the name and address of the manufacturer. In addition, labeling may include prescription use restrictions, information for use (including indications, effects, routes, methods, and frequency and duration of administration; and any relevant hazards, contraindications, side effects, and precautions), instructions for installation and operation, and any information, literature, or advertising that constitutes labeling under Part 201(m) of the FD&C Act.

The indications for use is based on the nonclinical and clinical studies described in the PMA. Indications for use for a device include a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. Any differences related to gender, race/ethnicity, etc. should be included in the labeling.

During the review process, FDA will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft final labeling. Approval will be based on the condition that the applicant incorporates the specified labeling changes exactly as directed and submits to FDA a copy of the final printed labeling before marketing.

Additional guidance on labeling can be found in the following guidance documents. The guidance documents are organized in the following categories: PMA Labeling Guidance; General Labeling Guidance; and In Vitro Diagnostic Device Labeling Guidance.

PMA Labeling Guidance

Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3)
http://www.fda.gov/cdrh/g963.html

Review of Final Draft Medical Device Labeling (Blue Book Memo #P91-4)
http://www.fda.gov/cdrh/p91-4.html

General Labeling Guidance

Alternative to Certain Prescription Device Labeling Requirements
http://www.fda.gov/cdrh/comp/rxlabeling.html
http://www.fda.gov/cdrh/comp/rxlabeling.pdf

Device Advice - Labeling Requirements
http://www.fda.gov/cdrh/devadvice/33.html

Device Labeling Guidance #G91-1 (blue book memo)
http://www.fda.gov/cdrh/g91-1.html

Draft Report on Medical Device Labeling: Patients` and Lay Caregivers` Medical Device Information and Labeling Needs - Results of Qualitative Research
http://www.fda.gov/cdrh/humfac/humfaclabel.pdf

Electronic Labeling: 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
http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.html
http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.pdf

Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
http://www.fda.gov/cdrh/ohip/guidance/1128.html
http://www.fda.gov/cdrh/ohip/guidance/1128.pdf

Human Factors Principles for Medical Device Labeling
http://www.fda.gov/cdrh/dsma/227.html

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
http://www.fda.gov/cdrh/dsma/470.pdf

RX Labeling: Alternative to Certain Prescription Device Labeling Requirements
http://www.fda.gov/cdrh/comp/rxlabeling.html
http://www.fda.gov/cdrh/comp/rxlabeling.pdf

Write it Right
http://www.fda.gov/cdrh/dsma/897.pdf

In Vitro Diagnostic Device Labeling Guidance

Guidance on Labeling for Laboratory Tests; Draft
http://www.fda.gov/cdrh/ode/1352.html
http://www.fda.gov/cdrh/ode/1352.pdf

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Updated 6/11/2003

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