Strategies to Meet the Expectations of FDA Approval Policy

By Kelly Shelton   02/06/2020

  Category: Other Blogs

With the advancement of technology, medical science has also taken a big leap for becoming one of the most updated sectors where daily new researches are conducted, resulting in the flourishment of improved medical devices that will increase the comfort level of the patients. In this competitive global market, it is a big task to introduce and advertise these newly produced gadgets and devices of a medical company in front of the widespread population. This is because the procedures involve auditing, face FDA regulation challenges, and pass the ISO certifications require a lot of time and complexity. It also may happen that the product may fail in any of the steps and require- structuring, which is also a money wastage. In this scenario, the medical device consulting services and agencies serve the role of an advisor and guide at every step to prevent any hassle.

In most cases, the medical device consulting firms contractors are appointed by companies when their product fails any audit. This is an even worse condition because they need to pay the agents as well as reconstruct their products. The agents will take care of the proposed product from the stage of production till the period it is successfully launched in the market. Even after that, they will keep tracking whether the product is performing well in the market and meeting customer expectations.

The following steps are adopted by consulting firms:

Uniqueness criteria fulfillment: To get the approval of the FDA, there should be some unique features that will attract the consumers. The features include mainly cost and quality. The pricing should be affordable by any section of the society, and quality should be as good as possible. Hence a proper plan is needed that will help the manufacturer getting the approval smoothly. These agencies will take care of it, do proper research, and suggest a constructive plan of action for knowing the market demand and the basic need of proper alternatives that consumers want. The alternatives are required, maybe due to the fact; the products are not meeting up to the expectations.

Also Read: Principle of Quality Assurance of a Drug – FDA Validation

Leaving a good impression of the FDA: During the occasional meetings, FDA asks the company some critical questions that are diplomatic. Without proper experience and thinking ability, it is difficult to answer those questions. These agencies will conduct several rounds of mock interviews with the firm owner and make them able to answer any question of the FDA board with full confidence.

Weighing the risk factor: A medical device will conquer the market only when it will solve the contemporary risk and hazards that similar products are creating in the market. The products sold may be similar in pricing but are creating hazards. The consumers are bound to buy these products even after knowing that they are creating hazards. This risk management study is done by medical consulting firms. It will track and record the human interaction with the proposed device, whether it can give relief from the hazards, whether the consumers are satisfied with the pricing, and submit the report to the FDA. This will create a good impact on the FDA for the manufacturer and his product.

Acknowledge of quality standards: Good Clinical Practice(GCP) and Good Manufacturing Practice(GMP) are the two standards that should be agreed on for a proposed medical device, and it is tough work. The agencies will help the companies to pass these standards with flying colors.

FDA registration: A company must get annual registration from FDA for production and distribution, which is a difficult job. FDA checks the set-up locations of the medical devices and does scrutiny in enlisting all the devices that are produced from a particular location.

Evaluating the classification: A particular device at first needs a classification among class1, class2, and class3. Then Center for Devices and Radiological Health (CDRH) will permit based on the documents of classification submitted. Then only the medical device can be sold in the market. This classification analysis is a complicated job and needs a lot of expertise. The firms will classify the proposed medical product on certain parameters like hazard level, safety procedures, and quality management.

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