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Biotech / Medical : Calypte Biomedical Corporation (CALY) -- Ignore unavailable to you. Want to Upgrade?

To: JanyBlueEyes who wrote (201)	11/9/1997 2:26:00 PM
From: JanyBlueEyes	Read Replies (1) \| Respond to of 381

LABELING It has been approx. 7 weeks since FDA gave approval pending labeling. Labeling is closely scrutinized by the FDA. Since Calypte's test is the "first and only" of it's kind, the FDA will take the time to evaluate all materials. Liability is an issue. See devicelink.com In product liability cases, the practices used by a device manufacturer to develop its product labeling could play an important role in determining the outcome of the trial....... ........."If a device-related event leads to a product liability suit, manufacturers should be prepared to show that they have observed state-of-the-art practices in developing their labeling--including their instruction manuals,"........... ..........manufacturers are exploring a variety of innovative techniques for communicating with end-users. Product information is no longer the preserve of printed manuals. "Companies are developing in-service videos, creating interactive computerized manuals that make use of touch-screen technologies, and even using the Internet to distribute product updates and safety alerts," said Ross. "Companies that do not explore all of these options could be putting themselves at risk in liability cases." From the FDA on labeling. See fda.gov All product packages (except surgical instruments) must bear a label (display of written, printed or graphic matter upon the immediate container of any article or on the article itself) including the name of the device, the manufacturer, and the address of the manufacturer. This Labeling refers to all labels and other written, printed or graphic matter: 1) upon any article or any of its containers or wrappers, or 2) accompanying such articles (Section 201(m) of the Federal Food, Drug, and Cosmetic Act) [2]. This definition is generally extended to include audio or video recordings whether in analog or digital format. It is critical that you write labeling so that the intended target audience can read and understand it....... .............labeling should include an objective and accurate representation of the clinical experience with the device whereby the practitioner and patient are made aware not to expect a completely safe and effective outcome with the use of the device in all cases. All sections of the labeling, particularly INDICATIONS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE EVENTS, and CLINICAL STUDIES, should reflect this balance. The detail of the product labeling should be appropriate for the needs of the user of the device as summarized below. 1. BRIEF DEVICE DESCRIPTION 2. INTENDED USE / INDICATIONS 3. CONTRAINDICATIONS 4. WARNINGS 5. PRECAUTIONS 6. ADVERSE EVENTS 7. CLINICAL STUDIES 8. INDIVIDUALIZATION OF TREATMENT 9. PATIENT COUNSELING INFORMATION 10. CONFORMANCE TO STANDARDS 11. HOW SUPPLIED 12. OPERATOR'S MANUAL 13. PATIENT'S MANUAL 14. REFERENCES