CDS Coalition Seeks Industry Input on the Elements of FDA's Proposed Software Precertification Program |
1.
Background
The following survey is 11 questions. This should take about 10-15 minutes.
On August 1, 2017, FDA announced plans to pilot a program designed to identify a new paradigm for regulating software that acts as a medical device without being connected to a hardware medical device. You can read about their program at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/Default.htm
The goal is to identify a streamlined regulatory path to market that offers equivalent safety and effectiveness but through an expedited pathway. Any new alternatives identified will need to be as reliable as the existing ones in ensuring safety and effectiveness, just as the TSA pre-check program does not reduce airline safety. Instead, the TSA pre-check process exchanges certain aspects of the security checks at the point of boarding a plane with a single pre-check that includes extensive background checks.
The purpose of this survey is to identify (1) the existing FDA regulatory controls that are the most burdensome, and (2) alternative requirements that industry would find acceptable as replacements. In the TSA pre-check analogy, think of it as identifying areas like leaving shoes on, coats on, and computers in bags, in exchange for agreeing to be interviewed, fingerprinted, and have an FBI check run on you.
On August 1, 2017, FDA announced plans to pilot a program designed to identify a new paradigm for regulating software that acts as a medical device without being connected to a hardware medical device. You can read about their program at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/Default.htm
The goal is to identify a streamlined regulatory path to market that offers equivalent safety and effectiveness but through an expedited pathway. Any new alternatives identified will need to be as reliable as the existing ones in ensuring safety and effectiveness, just as the TSA pre-check program does not reduce airline safety. Instead, the TSA pre-check process exchanges certain aspects of the security checks at the point of boarding a plane with a single pre-check that includes extensive background checks.
The purpose of this survey is to identify (1) the existing FDA regulatory controls that are the most burdensome, and (2) alternative requirements that industry would find acceptable as replacements. In the TSA pre-check analogy, think of it as identifying areas like leaving shoes on, coats on, and computers in bags, in exchange for agreeing to be interviewed, fingerprinted, and have an FBI check run on you.