FDA hopes draft guidance on-device software will offer ‘clarity, simplicity

Last week, the US Food and Drug Administration released a manual for premarket application content for application software.


The guide, published online Nov. 4, is intended to provide information on the recommended document for inclusion in the premarket application for the FDA to evaluate the safety and efficacy of the device’s software services.

FDA recommendation regarding device software services: Medical Device Software (SiMD) and Software as Medical Device (SaMD), preferably, and specify the data to be collected and recorded during design, development, approval, and validation.

The directive, once completed after the public content period, will supersede the FDA guidelines for more than 16 years for the content of the premarket installation of software on medical devices.

It represents a major revision of the document, published in May 2005, when it was impossible to imagine a viable technology. As the maturity and power of medical devices have improved since then, so has the organizational structure of the company.

The new document “describes the information that the FDA considers important during a safety and efficacy evaluation for device software with one or more device functions, including both software as medical devices and software as medical devices,” said Bakul Patel. , director from the FDA’s Center of Excellence for Digital Health and the Center for Devices and Radiological Health.

Details can be provided online before February 2, 2022.

Patel said, “We look forward to receiving feedback on this document guide, as well as providing participants with a final guide as part of our efforts to promote a new set of safe and effective tools for the benefit of public health.”


Speaking a year ago about the promise and potential of healthcare technologies, especially as human intelligence and machine learning evolve, Patel introduced a comprehensive FDA product lifecycle system for AI-approved applications fast-growing for medical devices.

The goal, he said in October 2020, is that “FDA monitoring will provide employees with a level of confidence and assurance while improving pre-market understanding and peace of mind, as well as ongoing monitoring.” is being studied. We look forward to seeing what we can do to promote this ongoing process and to understand how management systems can do just that. “

Meanwhile, last month, the company published another document: a list of “guidelines” to help promote the safe and effective use of medical devices that use AI.

This hope is to lay the foundation for what the FDA calls fair learning. “As the AI / ML medical device region grows, so will GMLP’s best practices and contract standards,” the company said.


“As technology continues to advance in all areas of healthcare, the software has become an integral part of many products and has been incorporated into medical devices,” Patel said last week, announcing the handheld software and hardware.