Release date: 2008-03-24
The U.S. Food and Drug Administration (FDA) sets performance standards for medical devices and requires pre-market approval for certain types of equipment. According to the Code of Federal Regulations, Class I, II, and III medical devices are all subject to general regulatory requirements, such as business registration, product registration, Good Manufacturing Practices (GMP), labeling rules, and pre-market notifications. However, for some Class II and III devices—like power wheelchairs, infusion pumps, surgical drapes, and others—the FDA may require additional controls beyond general management to ensure their safety and effectiveness.
Class III medical devices are considered the most highly regulated due to their potential risks or critical role in patient care. These devices are often used to sustain or extend life, protect health, or pose significant risks if they fail. Examples include heart valve replacements, breast implants filled with silicone, and implanted cerebellar stimulators. Because of this, these devices typically require a Pre-Market Approval (PMA) application before they can be marketed in the U.S.
The PMA process is the most rigorous review by the FDA, involving extensive scientific evaluation of the device’s safety and effectiveness. Unlike other classifications, Class III devices cannot rely solely on general controls or performance standards. Under Section 515 of the Federal Food, Drug, and Cosmetic Act, these devices must undergo FDA approval prior to commercial distribution.
Enforcing performance standards involves several key components, including defining the device's functional characteristics, its design and materials, compatibility with other systems, manufacturing processes, quality control procedures, inspection methods, and the reporting of test results. Manufacturers must also provide documentation confirming that the device meets all applicable standards and maintain proper labeling and distribution practices.
The PMA submission must be based on solid scientific evidence, including clinical data, analytical studies, and thorough documentation. If the information is incomplete or lacks sufficient validation, the FDA review process can be significantly delayed, potentially affecting the device's market entry. The FDA typically takes at least 180 days to evaluate a PMA application, ensuring that the device is safe and effective for its intended use. ——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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