Draft Guideline for Industry and Food and Drug Administration Staff

Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate

Format for Traditional and Abbreviated 510(k)s, and the section of CDRH’s Device Advice, Premarket Notification Submission 510(k).

FDA also has issued a draft guidance on the procedure and criteria related to the administrative completeness of 510(k) submissions, Draft Guidance for Industry and FDA Staff: Refuse to Accept Policy for 510(k)s.

Guidance for Industry and FDA Staff: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, August 21, 2008

Guidance for Industry and FDA Staff: Updated 510(k) Sterility Review Guidance K90-1, August 2002¹. For FDA’s current thinking on labeling and validation methods for processing of medical devices, see Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, April 1996².

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The 510(k) submission must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e) and 21 CFR part 801.

The labeling described in this section is not intended to be exhaustive but represents some basic information that is to be included as part of the TMCRP device labeling provided to surgeons and patients. Supplement this labeling with information sufficient to inform surgeons of the limitations and proper use of the device and to enable them to achieve satisfactory results. This may include instructions for patient selection, component selection, and site preparation, proper placement of the device, site closure, and follow-up patient care.

Because TMCRP are prescription use devices, in accordance with 21 CFR 801.109(b)(1), labeling must include the statement â€œCaution: Federal law restricts this device to sale by or on the order of a physician.â€

8.1 Professional Labeling

Include professional labeling addressing the contraindications, warnings, precautions, and general risks associated with the device, as required by 21 CFR 801.109. This includes the following:

A. Contraindications

Include contraindications for use of the device by:

patients with temporomandibular joint (TMJ) disorders or with traumatic injuries to the condyle;
patients with metal allergies and foreign body sensitivity; and
patients with limited blood supply or inadequate bone at the site.

B. Warnings

Include these warnings:

TMCRPs are intended only for temporary fixation (less than 24 months) and only in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for permanent implantation or for treatment of patients with TMJ disorders.
Single use only. Do not re-use.
Avoid direct metal to bone contact between the condylar component and the natural glenoid fossa. A soft tissue interface should be used between these surfaces.
Do not use plates, screws, and other components of dissimilar metals together at the implant site.

C. Precautions

Include these precautions:

Failure to use the appropriate components, provide rigid fixation, and maintain an adequate blood supply may result in implant loosening, bending, or fracture of the implant and/or bone.
Postoperative care should consist of a soft-food diet until bony healing occurs (6-10 weeks). Afterwards, normal biting forces associated with an unrestricted diet may not be tolerated with this implant.

D. General Risks

Include a discussion of the general risks associated with the device, including the following:

implant loosening, migration, or exposure;
degenerative changes to the natural articulating surfaces;
malocclusion and changes in mastication and the contralateral joint;
foreign body reaction;
loss of implant integrity;
transient or chronic pain/ facial nerve paresis; and
infection.

8.2 Patient Labeling

Patient labeling is to be included and the following statements and/or principles must be addressed:

Duration of implantation: The temporary mandibular condyle reconstruction plate is intended for temporary use (defined as less than 24 months) only. It is not intended to permanently reconstruct the TMJ. It is not intended for permanent treatment of TMJ disorders.
Instructions to the patient regarding the following aspects:
- Notification that normal biting forces may not be tolerated with this implant.
- How to appropriately avoid trauma to the implant site.
- Discussion with the surgeon about an appropriate diet to follow after implantation of the device.
Inclusion of possible complications and/or adverse reactions from the use of this implant.
The patient should be instructed how to report any complications or unusual changes to the surgeon or FDA.
A glossary of medical terminology.

For FDA’s current thinking on development of patient labeling, refer to Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, April 19, 2001.

^{Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.}

^{Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.}

³ Final labeling must comply with the requirements of 21 CFR part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling criteria in this guideline are consistent with the requirements of part 801.

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