Sample Record for Search: FDA Warnings

April 12, 1993
Mr. Lawrence A. Reed
President
Dow Corning Corporation
2200 Salzburg Road
Midland, Michigan 48686
Re: Silastic H.P. Sheeting
Silastic Medical Grade Sheeting (Preamendment)
Silastic TMJ Implant H.P., Wilkes Design (COPY DELETED)
Dear Mr. Reed:
It has come to our attention that Dow Corning Corporation has been promoting and commercially distributing the above referenced dental implant devices,intended for use in the temporomandibular joint (TMJ). These products are devices as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our records indicate that your firm has not submitted a premarket notification for the Silastic H.P. Sheeting, as required by section 510(k) of the Act. Failure to submit a premarket notification (510(k)) at least ninety (90) days prior to the intent to introduce a device in interstate commerce is a prohibited act under section 301(p) of the Act, and results in the device being misbranded within the meaning of section 502(o) of the Act.
Should the Silastic H.P. Sheeting be found not substantially equivalent to existing class I or class II devices, then the device is classified by statute in class III, requiring an application for premarket approval (PMA) to support the safety and efficacy of the device. Failure to submit a PMA application prior to marketing a class III device adulterates the device under section 501(f)(1)(B) of the Act.
We also note that the Silastic H.P. Sheeting contains (COPY DELETED), and the agency will need data on the consequences of migrating (COPY DELETED) wear particles, which contain the (COPY DELETED).
The Silastic TMJ Implant H.P. (Wilkes Design) is misbranded under section 502(a) of the Act, because the labeling changes have not been cleared by the FDA during premarket notification (COPY DELETED). The premarket notification specified intended use for implantation following meniscectomy, and device removal approximately four months postoperative. However, subsequent labeling revisions bear new indications for use, reconstructive procedures, and postoperative implant removal times. Therefore, a new premarket notification is required.
The labeling for the Silastic Medical Grade Sheeting fails to bear specific directions for use, relevant hazards, warnings, precautions, contraindications, or side effects, as required by section 502(f)(1) of the Act.
Continued distribution of the Silastic H.P. Sheeting, Silastic TMJ Implant H.P. (Wilkes Design), and Silastic Medical Grade Sheeting) can result in a regulatory action without further notice. The action may include, but is not limited to seizure, injunction, and or civil penalties.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. A copy of this letter has been provided to the Detroit District Office, 1560 E. Jefferson Avenue, Detroit, Michigan 48207. We request any action taken to remove the product from the market be reported to them.
Your response to this letter should be sent to FDA, Center for Devices and Radiological Health, Regulatory Guidance Branch (HFZ-323), 1390 Piccard Drive, Rockville, Maryland 20850, to the attention of Mr. Gerald Shipps.
Sincerely yours,
Ronald M. Johnson
Director
Office of Compliance
and Surveillance
Center for Devices and
Radiological Health
LEF

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