FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
At the MedCity INVEST Conference in Chicago, the FDA's Bakul Patel spoke about the recent developments in the agency's thinking about regulating the emerging Software as a Medical Device space.
Based on the literature review conducted by the researchers, only 14 percent of top ranked behavioral health apps described design or development that was based on real-world evidence.
At a workshop convening digital therapeutics companies at the DTX West meeting in San Mateo, California, stakeholders debated what was necessary to build successful business models in the industry while navigating a nascent regulatory pathway.
A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.
FDA Commissioner Scott Gottlieb further clarified the pilot program meant to expedite review of digital health technologies and incorporate real world evidence into the regulatory process.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.