by John Smith Digital Marketing Expert
Each year FDA publishes data on clearance of medical devices done through a Premarket Notification Program called 510(k). Instead of approving, FDA gives clearance for selling them in the market. This step is taken to increase the sales of certain medical devices. The manufacturer gets advantageous ways through this program to launch its product at a faster pace in the global market. FDA 510(k) allows a newly produced medical gadget to get FDA approval by comparing it with the products having similar features and that are already selling in the market. FDA gives permission in the classification of class1, class2, and class3 segments, which is a three-tier classification system. Each medical device classification is associated with a probability of risk factor. If the number of classification is more, greater risk management procedures should be adopted.

• Class 1 medical device - They have a low to moderate level of risk to the patient. Only 47% of medical devices come under this type. Elastic bandage, stethoscopes, and bedpans are examples. They exist in their purest forms and have the very least chance of getting polluted or contaminated.

• Class 2 medical device - They have a moderate to a high level of risk to the patient. 43% of medical devices are come under this type. Powered wheelchairs and pregnancy test kits are examples. They may have technical faults somehow, one in a batch; hence the defect is easily traced by the consumer and replaced before utilization. But if they are consumed in their defective form, consumers suffer.

• Class 3 medical device - They have high to severe levels of risk to the patient. Only 10% of medical devices are identified in this section. Breast implants and permanent pacemakers are examples. Since they remain attached to the human body, any defect may affect the physiological functioning of the individual. Hence great care should be taken by the manufacturer for their production else the consumers may suffer throughout their life wearing those artificial products. He/she will be suffering internally without having known about it. 

The following steps give a brief idea of how a medical device gets permission through the FDA 510k:

• Identifying the classification of the medical device: The medical device manufacturers analyses the presently selling medical devices classification and hence project that their product falls under this particular section of medical devices. Both price and quality are important parameters. 

• Locating the already FDA approved products in the market: From the FDA database, it is not difficult to find out such products, and hence after finding the similarities between current and proposed products, the parameters are tallied. This browsing process will give an edge to the manufacturer to trace what are the major drawbacks that are still faced by the products selling in the market. These drawbacks can be used as key points that will help the proposed product to make a position in the top ranks of the sales market by manipulating the other competitors. As a whole, the consumer is benefitted by getting good to the best quality of service and products.

• Searching for applicable standards: Using FDA product classification Code, the firm searches for special guidelines, instructions or international standards that will support promoting their proposed device as they are mandatory along with the FDA 510k process else the proposed product may fail to get the approval of FDA team due some standards not matching with the guidelines.

• Submission of Approval application: The medical company now submits performance tests, research papers, required standards, and similarity proofs valid for the proposed product.

• Review of approval application by FDA: Within 90 days, FDA examines the entire process and charges an additional amount of money for the fast-track 510(k) approval process. Once the review procedure is complete, a clearance or no-objection certificate is sent to the manufacturer with a 510(k) identification serial number.

• Registration in FDA website: The medical manufacturer first registers with the FDA website by the identification number if he has not sold medicines before. Then he enlists his FDA approved product on that website. For selling the product, the FDA claims a yearly amount of money from the manufacturer.

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About John Smith Senior   Digital Marketing Expert

343 connections, 3 recommendations, 970 honor points.
Joined APSense since, June 14th, 2012, From Delhi, India.

Created on Feb 6th 2020 20:58. Viewed 313 times.


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