The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016.
In line with the Center’s published priorities for 2016 (more on that next time), the application of human factors and usability engineering to medical device design makes it onto the list, as well as incorporating patient preferences into device premarket approvals.
The resolutions are split into
- The A List (those draft and final guidances the FDA “fully intends to publish”), and
- The B List (those that will be released “as resources permit”).
We are curious to see which of the comments made by industry are included in the Final Guidance documents.
You can read what others in the industry, such as Eli Lilly, Smiths Medical and GSK, are saying at the US government website www.regulations.gov. Search for the relevant guidance document (e.g. human factors FDA will find the agency’s draft guidance document on that topic).
Amongst the Final topics that made it onto the A List are:
- General wellness products
- Medical device accessories
- Incorporating patient preferences into medical device premarket approvals, humanitarian device exemptions, and de novo classifications
- Applying human factors and usability engineering to optimize medical device design
- Post-market surveillance studies under section 522 of the Food, Drug, and Cosmetic Act
- Medical device reporting for manufacturers
Draft guidance topics that reached the A list included:
- Medical device decision support software
- Use of symbols in labelling
- Software modifications
- Companion diagnostics co-development
- Use of real-world observational patient data to support decision making for medical devices
- Public notification of emerging post-market medical device signals
The B List also has some guidance topics which are keenly anticipated, however these will only be progressed if resources and time permit during 2016:
- Blood glucose monitoring test systems for prescription point-of-care use (Final)
- Self-monitoring blood glucose meters for over-the-counter use (Final)
- Medical device interoperability (Draft)
- Patient access to information (Draft)
- Defining the UDI (Draft)
It doesn’t stop there, as there’s been a wealth of Guidance published by the agency over the past few decades. The FDA has asked for feedback on many Guidances published more than 10 years ago, to see if they should be revised or even removed.
Of note are:
- Do It By Design (the FDA’s 1996 introduction to Human Factors in Medical Devices)
- Post-market Surveillance under Section 522 of the FD&C Act (a 2006 Final Guidance)
Read the FDA proposal here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm