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FDA – the Main Regulatory Body for Keeping Public Healthy
Regulatory bodies are essential in this day and age for keeping public health standards and preventing future illnesses. They are true allies of the people and not corporations. Setting highest standards, imposing requirements and enforcing the laws, establishing rules and restrictions, securing, enforcing and monitoring compliance as well as enforcing non-compliance – these are the main and the vital responsibilities of the goal-oriented regulatory body. The rhetoric behind regulations is that they are put in place to protect, and they do just that. The best way to measure the success of the regulations is the saved lives, and the worst is to join the anti-regulatory ideology crowd and measure its value in currency.
Regulatory bodies are mandatory in any industry or profession, and so much so, when regulatory policies are imposed and exercised in the field of public health promotion and protection, here regulations truly become life-saving. Health and health-adjacent matters are where people find themselves most vulnerable and need the most protection.
If history has taught us anything at all – it is that we need regulations. It has been proven time and time again: corporations need the system of checks and balanced or they will poison us all. Without appropriate regulations being enforced and controlled thereafter no one can feel safe and secure. This is the exact reason why regulatory bodies were established long ago, the absence of regulation and thus lack of accountability resulted in human casualties that could have easily been avoided with a simple set of rules. Nowadays it’s pretty much a non-negotiable: absolutely all products that may have an impact on health are heavily regulated as to avoid causing harm. And the main regulatory body setting all the rules and creating clear guidelines for health standards while making sure that objectives of regulations are being achieved is the FDA.
What is FDA?
U.S. Food & Drug Administration is a federal agency of the Department of Health and Human Services. The main responsibility of the USFDA is the protection of health by setting legal limits and enforcing the system of proper compliance by surveillance and monitoring. Agency mainly focuses on making rules and regulation effective and efficient by influencing the behavior of those being regulated, monitored and certified. Another important responsibility always at the top of the list of priorities is the product and equipment advancements and innovations. Nowadays, it is not that uncommon to come across a headline such as: “FDA Approves a New Way For Scientists to Use Gene Therapy” or “FDA is working on approval of the revolutionary CAR T-cell therapy for treating cancer”. Recently FDA had presented an Action Plan that Promotes Innovation to Make Medical Devices Much Safer.
Their stated mission of keeping people healthy hasn’t changed from the day the Agency was founded more than a hundred years ago. The regulatory programs vary for different groups of products, they undergo extensive scrutiny before obtaining a USFDA certificate. Regulation accrues across all of the processes starting from research, testing, manufacturing and up to the marketing and labeling. The regulations accrue with the set of standards that are enforced by almost 10 000 employees of the Agency.
FDA’s jurisdiction extends to the full oversight of a very extensive list of product groups.
In general, they regulate the food supply, including cosmetics and dietary supplements, nutrition formula for infants, bottled water and much more. In the medical field, regulatory policies extend to all drugs, the vaccines are also supervised and, actually, a lot of biological products like blood, bone grafts, soft tissue grafts, etc. It is also fully responsible for the medical devices. This category includes a huge line of medical products starting from the simplest ones like a bedpan or an IV pole and stretches to the top of the line to the very complex cutting-edge technologies, like pacemakers or ultrasound therapy machines. List of medical devices is large and impressive and includes, though not limited to, the implant and prosthesis product groups, and the multi-billion dental industry, where it is responsible for imposing legal limits for everything from basic tweezers or a tongue holder to dental implants.
Then there is a huge category of the equipment and products that emit radiation. Again, in this swimmingly uncomplicated category, you’ll be able to see a cutting-edge x-ray machine and a basic household staple like a microwave oven or even a simple mercury lamp.
Agency also manages and monitors the tobacco products, covers all of the veterinary industry, including veterinary foods and drugs, plus its regulatory powers spread to the fabulous products of the cosmetics industry. So, anything and everything - from mascara to perfume or a bath bomb is in fact regulated.
The agency was created by the Congress in 1906 to address the safety violations in the food industry as the government took notice of the public health implications at stake. Though originally the authority of the Agency was quite limited and restricted since it began its journey with the Pure Food and Drug Act. Later on, safety concerns, as well as the number of deaths caused by drugs, drove the Government to expand the regulatory authority of the federal agency and it was given more power in 1938, and once again calls for further restrictions and concerns for inadequate drug testing and poor accountability has resulted in the expansion of the authority of the FDA in in 1962. These dates are truly the life-saving milestones.
In 1976 the device regulation was added and from that point, all of the medical devices had to be cleared with the Agency prior to entering the market. To give you an idea on the evolution of the FDA here’s a number: it took more than a 100 bills for the FDA to take on a form of the Agency we know today.
The very difficult device regulation amendment had to be separated from the other groups and the Center for the Devices and Radiological Health of the CDRH was born. The Centers mission, just as the overall FDA mission, is to promote and protect the public health. The CDRH oversees, first of all, safety and the quality, effectiveness of all medical devices and devices that emit radiation of any kind. They set the regulations, and assure the predictability, as well as transparency and consistency in their device certification process.
What Is the Process Of Receiving the FDA Certification?
Those being regulated undergo a lengthy, scrupulous and very thorough step-by-step process to finally be eligible to receive the USFDA Certificate. At times the products get rejected in the final stages of the testing process if the safety requirements fail to be met. Having spent tons of money on the invention, testing and manufacturing those companies usually blame failed product or device on the unfair policies and over-regulation of the whole process and they usually find themselves on a losing side of an argument. USFDA supervises the extensive testing as well as the manufacturing, everything is closely monitored so officers can pinpoint and report on every single health concern.
USFDA stamp of approval in the form of the issued certificate has an air of gravitas that commands respect for a reason, or, one might say for a hundred different reasons. Involvement starts right from the point of any product reaching the point of being tested on humans. At this point there is a requirement for the IND (Investigation of a new drug) report that must be filed, the company has to submit a comprehensive report with all of the required data. Though research is done by the companies, the guidelines are set by the USFDA Center for Drug Evaluation and Research. A number of trials, specifics, conditions are all set by the CDER and must be precisely complied with and followed. The process isn’t rushed, there are never steps skipped or data overlooked when reviewed by the panel of scientists and industry experts.
The FDA Compliance
Any given company must be able to fully cooperate, understand and follow laws, rules, regulations as well as the safety guidelines. It is a highly scrutinized process dreaded by companies. But, one must always remember that this is a process put in place to protect the public from huge corporations and surely not the other way around. A lot of efforts are aimed to the proper in-depth process of product identification and future tracking. Labeling, lot and or batch numbers, expiration dates are all to be kept in order for a company to be UD FDA compliant. A lot of regulations, as well as postmarked surveillance, also help in the unfortunate event of a possible product recall. Warehouse, storage, inventory and all of the process starting from manufacturing and labeling – all of the regulations ought to be followed to the dot in order to recall potentially harmful products from the shelves ASAP. The ability of the company to properly set up the business process is, in fact, crucial to stay USFDA Compliant.