In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices that are sold in the United States. It also regulates electronic products that emit radiation. These products include lasers, x-rays, ultrasounds, microwaves, and color televisions.
Radiation-emitting Electronic Products
Medical devices are broken down into three classes, Class I, Class II, and Class III. Class I has the least amount of regulatory control and are exempt from having to submit a Pre-market Notification 510(k) for approval. Class II devices; however, require Pre-market Notification 510(k). Class III devices require Pre-market Approval and the approval of two groups. Continue reading
medical device compliance
If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a rigorous process and there are fees involved as well. Medical devices can fall under three separate classes that are relevant to the FDA compliance approval process, and, in the following, they are explained in much greater detail. Getting a medical device approved can be done a couple of different ways.
After you put together your creation, you must determine what classification it is. The three classes are simply known as class I, II, and III. What property earns the devices this classification is usually the risk it offers users. The lowest level, class I, is associated with devices that are not harmful to consumers in any way. Tongue depressors and thermometers are both types of class I devices. These have a relatively easy procedure to follow to get approved by the FDA. Continue reading
Companies that make drugs are always analyzing various compounds trying to find the ones that have the most therapeutic value. There are many steps, millions of dollars, and thousands of man hours spent on trying to get a medicine approved by the FDA. There are many steps to get your product approved before you can sell it on the open market.
Perfection and Preclinical Testing
During the first six or seven years of preclinical testing the synthesis and purification of a drug gets perfected by the manufacturer. Limited animal testing applies as well. Out of thousands of compounds that are tested, only a few will appear to have enough promise to induce a company to file an IND, or Investigational New Drug Application. If the FDA approves the IND and an Institutional Review Board approves them as well, the manufacturer can start the first part of development. Continue reading
An Electronic Common Technical Document, or eCTD, is a standard for electronic submission containing regulating information to regulated agencies. The document is an easy and quick resource that you can get a lot from using.
Where is eCTD currently accepted?
Regulating agencies that account for all of separate areas, including United States, Canada, the European Union, and Japan, all have accepted eCTD submission. They have set in place good medicinal compliance and device compliance that works to not harm the patient. Continue reading
If you have ever wondered how the Food and Drug Administration handles food guidelines, there is plenty of information you can learn about here and at their website. It has a pretty good run down of the guidance and regulations for the food service industry. Food safety programs are available that show an overview of the manufacturing process, systems of the industry, and import/export activities. Continue reading
There are many basic regulatory requirements that manufacturers and importers consider when they market medical devices. These rules are to aid foreign governments to understand the overall mission of the FDA. In addition, there are FDA regulations for marketing and exporting medical devices to and in the United States. It is very important to know the requirements and to know which ones are applicable for your product. Establishment registration, device listing, labeling requirements, classification, Pre-market notification [510(k)], medical device reporting, and good manufacturing practices are all significant to manufacturers and importers of medical devices. Here are some of the aspects of these requirements. Continue reading
Regulations for Medical Devices
Medical devices can be anything from highly refined computerized medical equipment down to a wooden tongue depressor. There are multiple international classification components to categorize medical devices. The World Health Organization, or WHO, with partners, are working toward accomplishing global harmonization in medical device terminology in hopes of bringing a global standardization.
The Global Harmonization Task Force proposes the following definition for medical devices: A medical device is any instrument, implement, apparatus, machine, implant, appliance, in vitro reagent or calibrator, software, or related article, as intended by the manufacturer to get used in combination or alone on humans for the specific purpose of: Continue reading
Medical compliance is the different laws and regulations that the FDA creates in the United States for the health and well-being of the consumer. There are laws and regulations for businesses that work in the food service industry, drug industry, animal care industry, tobacco industry, cosmetic industry, and companies dealing with medical devices and radiation-emitting products. There are even regulations of vaccines, blood, and biological products that are available. Here is some information about how each of these fields gets regulated by the FDA in America to help with compliance in these various areas of business. Continue reading
When knee replacements began to be used in the early ‘70s it was the common thinking that they would last maybe 10 years before needing to be replaced. For this reason, knee replacements were commonly only used for elderly patients. Over the years, there have been huge technological advancements in a wide variety of areas. Even though many improvements have occurred in surgical technique alone, it is not the only area which has undergone major changes. For instance there have been many improvements and advancements in the materials, design and fixation which have occurred which all work together to increase the durability of any type of joint replacement. In some patients, an orthopedic surgeon placed the knee prostheses as long ago as 30 to 40 years. But how long a knee replacement lasts varies greatly from one patient to another depending on many factors. Continue reading