Government is full of regulations for private companies to comply with. These regulations are meant to sift through all the companies which want to do business with the government. Among other things, there are accreditation procedures, which private companies have to follow and/or comply with. This is good for the government as it can expect private firms to deliver on time and within the budget.
The FDA wants to employ an approach of continually updating and upgrading their procedures, which will help improve innovation.
However, one problem with certification is that it takes longer to get certified than it does to comply with requests for a proposal. This can be a disadvantage for those companies who want to compete for government projects, but do not have any experience in government contracting. It can also demotivate new startups from going after government contracts. These companies have to go through accreditation procedures, as well as separate accreditation and certifications for their products and devices.
The FDA has acknowledged this issue with certification, and the need to have streamlined procedures in order to take advantage of advances in technology. Recently, the agency has launched a pilot program for pre-certification specific for innovations in digital health. This would affect tech companies of all types and sizes. It is a bold action that should help unleash new technology that can offer better health care at reduced cost.
Named the Digital Health Innovation Action Plan, the pre-certification program is aimed at a more relaxed set of regulatory requirements for digital health companies who have a proven track record for designing, developing and testing quality health care products. The aim of the program is to shorten the time needed for these companies to take their products to market. It would also result in lesser development costs, savings for the company and ultimately, the public.
FDA Program to Open Competition for Digital Tech
This program is open for software and hardware developers who have proven themselves to be reliable in manufacturing digital devices which are safe, effective and of high quality. It is also necessary that the tech companies have taken appropriate patient safeguards with their products and devices.
The pilot program will only have nine participating companies of various sizes and expertise. The FDA will be evaluating participants beginning in August. The digital tech product companies will be selected according to a specific set of criteria. The company must be currently developing a medical health product. The company must also have a track record in developing and testing their tech products, standing policies and procedures for maintaining the quality of the organizational processes, along with the necessary Key Performance Indicators.
Once accepted into the pilot program, the companies are also expected to provide information and data to confirm that the KPIs are being met, demonstrating a culture of excellence within the organization. The company also has to provide the FDA with actual post-market data, meet with the FDA for monitoring and consultation; along with the availability of onsite-visits, and provide information about the company’s quality assurance and management systems.
The FDA acknowledges that the traditional approach to certifying health products does not fit the current model for novel digital health devices. The FDA wants to employ an approach of continually updating and upgrading their procedures, which will help improve innovation. The framework for such a procedure does not yet exist. Any new regulatory procedure for digital health products should accommodate the distinctive nature of digital health technology as it keeps evolving.
