Answers to today's medical questions through blogs and articles

Treatment

How to Prevent Bad Breath

Cosmetic Treatments for WrinklesThere are many ways to prevent and cover up bad breath. It is important to know what is causing your bad breath to know what will work best in your situation. There are a variety of things that can be causing it that should be fixed in order to stop bad breath from returning. Here are some causes of bad breath and ways that you can prevent it from returning in the future.

Medical Device Regulations in Canada

Medical Device Regulations in Canada
Medical Device Regulations in Canada

His Excellency, the Governor General in Council, by the recommendation of the Minister of Health, pursuant to the Food and Drug Act, brought forth what was meant to be an answer to a common problem. Medical devices that were sold in Canada needed to be researched and regulated for the safety of the users. Regulations got passed that apply that the sale and advertising of medical devices, and the importation of medical devices. The rules also apply to in vitro diagnostic tools or products, as if the product were an in vitro diagnostic device themselves. Food and Drug Regulations, Controlled Drugs and Substances Act, and the Narcotic Control Regulations all state pretty clearly that you are to stay away from illegal and non-prescribed drugs.

Regulations for Medical Devices in America

Regulations for Medical Devices in America

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.

How to get new medical device approved?

medical device compliance
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.

Classification

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.

How to Get a New Drug Approved

PDA Approved
PDA Approved

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.

What is an eCTD?

eCTD
eCTD

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.

What Are the FDA Guidelines for Food?

FDA Guidelines
FDA Guidelines

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.

How Does the FDA Regulate Medical Devices?

FDA approved
FDA approved

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.

Who Regulates Medical Devices?

FDA Approved
FDA Approved

The FDA, or Food and Drug Administration, is an agency inside the U.S. Department of Health and Human Services. It makes up the office of the Commissioner and the four directorates oversee the core functions of the agency. From medical products and tobacco, to food and veterinary medicine, it helps to regulate operations for many industries in America.

Federal Drug Administration

The Federal Drug Administration is responsible for many things. First is being the regulator of tobacco. Beyond that, the FDA aids the protection of public health by making compliance regulations for the medical field, food service industry, and many more important parts of everyday life for American citizens.

Regulations for Medical Devices

Regulations for Medical Devices
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.

GHTF

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: