Release date: March 24, 2008
Under U.S. federal regulations, medical devices are classified into three categories—Class I, II, and III—each subject to different levels of oversight. Class I devices typically involve minimal risk and are regulated through general controls such as business registration, product registration, adherence to good manufacturing practices (GMP), proper labeling, and pre-market notifications. However, for certain Class II and III devices that cannot be adequately controlled by general measures alone, additional regulatory actions are required. These may include the establishment of mandatory performance standards to ensure safety and effectiveness. Examples include power wheelchairs, infusion pumps, surgical drapes, and other critical medical equipment.
Class III devices are the most strictly regulated due to their potential to support or sustain life, or because they pose a significant risk to patient health if they fail. Devices such as heart valves, breast implants filled with silicone, and implanted cerebellar stimulators fall into this category. For these devices, the Food and Drug Administration (FDA) requires pre-market approval (PMA) before they can be legally sold in the United States. This process involves a thorough scientific evaluation to confirm the device's safety and effectiveness.
The enforcement of performance standards includes several key components. These include defining the functional characteristics of the device, ensuring its design, materials, and compatibility with other systems meet necessary requirements, establishing appropriate manufacturing methods and quality control procedures, implementing testing protocols for both manufacturer and third-party inspections, disclosing test results, providing certification that the device meets all applicable standards, adhering to distribution regulations, and ensuring accurate and informative labeling.
Pre-market approval is a rigorous process, particularly for Class III devices. The FDA mandates this review under Section 515 of the Federal Food, Drug, and Cosmetic Act, as general controls and performance standards are insufficient to guarantee the safety and effectiveness of these high-risk devices. The PMA process requires extensive documentation, including clinical data, scientific analysis, and evidence-based reasoning. If the application lacks sufficient information, the review period can be significantly extended, delaying market entry. On average, the FDA takes at least 180 days to review a PMA submission. This stringent process ensures that only devices meeting the highest safety and efficacy standards reach patients. ——Shanghai Medical Device Industry Association
The main differences between powder,premixed agent, granule are as follows:
Veterinary Soluble Powder: means a dry powder preparation made of one or more drugs by grinding and evenly mixing, with or without dressing.
Premix: refers to one or more drugs, and a suitable substrate evenly mixed to make a powder or granular preparation.
As a dosage form of feed drug additive, it is specially used for mixed feeding.
Powder powder, that is, powder, and premixed agent, the main differences of granules are as follows:
1.the production method is different
1.powder: medicine or with appropriate auxiliary materials by grinding, evenly mixed dry powder preparation.
2.Veterianary premix: powder or granular preparation made by evenly mixing the drug with an appropriate substrate.
3.granules: raw materials and appropriate excipients mixed into a certain particle size of dry granular preparation.
2.different characteristics
1. Dispersing agent: compared with other solid dosage forms, dispersing agent is easy to disperse, dissolves quickly, absorbs quickly and takes effect quickly; The preparation process is simple, the dosage is easy to control, and it is easy for infants to take.
2.Premix for animal: Premix used in the matrix including carrier, diluent, etc. The substrate should be stable, with good fluidity, and easy to mix with drugs and feed.
3. Granule: the dispersion, adhesion, agglomeration and hygroscopicity of granule are lower than that of granule; The separation of various components in granule is avoided because of the adhesive used to make granule after mixing. Convenient storage and transportation; Particles can change their function by coating.
Veterinary drug premix,Premix for animal,Veterinary premix,Poultry premix feed
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