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Results for “Device Approval”

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At least 847 records · Page 47Linked to original sources
PubMed1999

Drug delivery: the strategic advantage of design controls.

An interesting dichotomy exists in the regulation of drug-delivery products. If they are regulated as devices, there is a strong likelihood that new products will be designed and developed under documented design control programmes. There is less chance of this if they are regulated as drugs. This article discusses the benefits and added value of designing and developing all drug delivery products under a documented design control programme.

Device Approval↗
PubMed1999

Ear, nose, and throat devices; classification of the nasal dilator, the intranasal splint, and the bone particle collector. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls). FDA is also exempting the devices from the requirements of premarket notification. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Bone and Bones↗
PubMed1999

Medical device warning letter pilot. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) is initiating a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The pilot includes eligibility criteria and procedures for the issuance of warning letters.

Correspondence as Topic↗
PubMed1999

Implementation of the mutual recognition agreement between the United States and the European Community; pharmaceutical GMP's and medical devices; establishment of a public docket and FDA contact points. Food and Drug Administration, HHS. Establishment of a public docket and FDA contact points.

The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site.

Device Approval↗
PubMed1999

Listing of color additives for coloring sutures; [phthalocyaninato(2-)] copper. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of [phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for general and ophthalmic surgery made from a blend of poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene). This action responds to a petition filed by Ethicon, Inc.

Color↗
PubMed2000

Liquid acrylic adhesive agents in interventional neuroradiology.

Treating patients with brain arteriovenous malformations by the deposition of liquid embolic agents, particularly cyanoacrylates, requires judgment, technical expertise, and experience. Even though the first deposition of cyanoacrylate in human brain arteries occurred more than 25 years ago, the relative rarity of the disease and the high risk for complications has kept this procedure from being universally applied. Physicians are fortunate that, within the past year, new and better catheters have become available, and with the promise of approved cyanoacrylate devices that are now being evaluated, the future looks bright. This article reviews the history, chemistry, and uses of cyanoacrylate.

Acrylates↗
PubMed1999

Rationale for using single-use disposable air/water syringe tips.

The research discussed in this article was conducted to study the inaccessible lumen surfaces of used and unused metal tips of air/water syringes using a light and a scanning electron microscope. Factors affecting the selection of air/water syringe tips were enumerated and compared. Patient and dentist acceptance of reusable and single-use air/water syringe tips for use in the oral cavity was evaluated. Although heat sterilization may destroy microbial organisms, the internal surfaces of metal tips were found to be rough, making them the focus of mineral and bioburden deposits. With regard to cleaning and sterilization, disposable tips were found to be more acceptable in clinical use than metal tips.

Corrosion↗
PubMed1999

New FDA draft guidance on premarket submissions.

The United States Food and Drug Administration (FDA) has issued a draft guidance document on the type of quality system information to be included in various premarket submissions. This is the same information that should be maintained at the manufacturing facility for devices subject to the premarket notification or 510(k) process. This article discusses the contents of the draft guidance and recommends that manufacturers send their comments on the guidance to FDA.

Device Approval↗
PubMed1999

Sensible technology.

Explore the source record for details and available documents.

Blood Vessel Prosthesis Implantation↗