One of the biggest obstacles facing biohealth startups is the fact that unlike other categories, they need to get FDA approval for devices, drugs and procedures. This is because it is forbidden by the FDA to market unapproved medical products directly to consumers. Exceptions are made by the FDA for trade shows, but only after filing for clearance. It is Paid Medical Trials that are undertaken that report back on whether the drugs that are seeking FDA approval are safe and have a positive effect on the patients that are dealing with the particular illness that the drug purports to help. trials 4 us offer paid medical trials and have helped to contribute to a number of different drugs and treatments being made available to people with a variety of different health issues.
Medical Device User Fee and Modernization Act
An act was signed into law in 2002 that authorized the FDA to attach a fee to its medical device product reviews. This fee applies to everything from product development protocols to premarket notification 510ks and can be very costly for companies. However, if the fees are not paid by the time of the application, it will be considered incomplete by the FDA and not accepted for filing.
There are some exemptions or waivers that apply to PMA applications, but for most companies, the process can still be very expensive and time-consuming, depending on the product. In fact, surveys have found that simply clearing all the regulatory hurdles can make up more than three-quarters of the cost associated with brining a medical device to the market. These findings were reported in a survey of more than 200 medical technology companies back in 2010.
The Third Party Option
With costs running into the millions of dollars, it is no surprise that many companies are turning to funding in an effort to get FDA approval. Companies such as Sonavex, Vasoptic Medical, Gel-e and AsclepiX Therapeutics are just a few who took advantage of funding – in this case from the Life Science Investment Fund – to assist with the FDA process.
Of course, even with the proper funding, the FDA 510k clearance process can still take a long time. Nevertheless, many companies are turning to accredited members of the FDA third party review program to help fast-track the process. The fact that making use of a third party review service also eliminates the need to pay the FDA user fee makes it even more lucrative for companies.
The FDA clearance process is very important, but so is the time to market. By making use of external sources for funding or reviewing, the burden on both the company and FDA can be eased.