Complete Guidance Of 513(G) Exempt Devices

About Complete Guidance Of 513(G) Exempt Devices

Section 513(g) of the Federal Food, Drug, and Cosmetic Act is providing a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device. The 513(g) exempt devices process is allowing a sponsor to ask questions such as whether FDA regulates a given device, if the device is…

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Regulatory Consulting and It Involves Categories

Regulatory Consulting and It Involves Categories

As FDA regulatory consultants since 1999, BTGI has consistently engaged with the FDA in meetings and negotiations on behalf of their clients. The THEM. They are worldwide in giving FDA administrative counseling administrations to European, Indian and other Asian medication designers looking for presence. Their specialized topics incorporate, yet are not restricted to following categories given…

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Drug product labeling FDA consulting

Drug Product Labeling FDA Consulting

The FDA has a duty to regulate the manufacture, sale, and distribution of both prescription and non-prescription drugs (such as over-the-counter or OTC drugs). A significant FDA role in regulating these drugs is supporting sponsors in their efforts to ensure adequate drug product labeling. In this study, they describe the different types of drug “labeling”…

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Various Duties Of 513(G) Submission

Various Duties Of 513(G) Submission

The medical industries will introduce a lot of medical devices. With the help of that people can get the ultimate benefits.The food and drug administration is invented in the section of 513(g). This section is applicable for federal food, medical and cosmetic device manufacture. It gives proper guidance for submitting, reviewing and responding to the…

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Importance and quality assessment of raw material suppliers

Importance and quality assessment of raw material suppliers

Make known the importance of the evaluation of raw material suppliers in the pharmaceutical industry, specifically.  Objectives:  Know the complete procedure carried out by large pharmaceutical companies to select suppliers of raw materials. Evaluate the impact of the Supplier/Vendor Selection and Qualification on the quality of the finished product. Know the advantages of an adequate evaluation of…

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pma submission

Importance of FDA Pre-Market approval

Premarket authorization (PMA) is a method by which the Food and Drug Administration reviews new medical devices and drugs. PMA is only allowed if the manufacturer can demonstrate safety and efficacy through “sufficient and well-controlled” studies conducted under harsh clinical conditions. Only then can the manufacturer start selling the product. A pma submission is required for any…

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