Today, FDA held a tweetchat to provide further clarity and answers around its guidance on mobile medical app regulation. The basic takeaway on the guidance (which can be found here) is … it’s good! It’s clear! It’s pro-innovation! That’s great for companies and developers, but doesn’t make for a very exciting Twitter exchange.
Essentially the types of medical apps the FDA intends to regulate are largely unchanged from the draft guidance, but impressively the areas where FDA intends to exercise enforcement discretion – in effect, a hands-off policy – are significantly expanded. As you may have read in my colleague, Brian Reid’s blog post on Sept. 24, big pharma and health care solution providers will, for the most part, be able to develop away with little interference.
Apps that help patients manage their own condition (without providing specific treatment suggestions), organize their personal health information, provide access to information regarding their condition or treatment, help them communicate potential medical conditions to care providers, automate tasks for care providers or enable patients to interact with their personal health records or electronic health records are all fair game.
And FDA certainly had its talking points down, per @FDADeviceInfo: “FDA’s final MobMed guidance supports innovation & protects consumers”. That was a message that got repeated.
FDA did provide a little more color around its philosophy:
• “Enforcement discretion” = FDA is not actively enforcing requirements for manufacturers to register and list with the FDA
• FDA will review apps in a way that balances risks/benefits without creating unnecessary burden for app developers
• The FDA guidance reflects its focused priorities on apps that pose greater risks to patients & is a big de-regulatory action
• Apps that require FDA review will be evaluated according the same risk-based system the agency applies to other medical devices
A brief recap of select Q&A from the tweetchat can be found below. The full tweetchat can be reviewed online at Twitter.com, #FDAapps:
Q. How will FDA be monitoring apps for compliance? Browsing the Apple/Google Play stores?
FDA: Our efforts are focused on education and clarity at this time; we are focusing on clarifying areas that need oversight and looking for voluntary compliance.
Q. Logging and recording data seems to be fine, but what about interpreting data and making care recommendations?
FDA: Apps that meet definition of a medical device but pose little risk to consumers are an area where the FDA is exercising “enforcement discretion”; however, making recommendations that change dosage would raise risk to consumers.
Q. Some dosing apps are simple calculations routinely used in clinical practice. Will FDA exercise enforcement discretion for them?
FDA: Yes – please see appendix B in guidance (pg. 23).
Q. Under what circumstances would FDA choose to alter its enforcement discretion paradigm as explained in the guidance?
FDA: We intend to follow this [enforcement discretion] policy unless we have new info that raises public health risk. If/when we change policies we will follow public processes.
Q. Is the FDA checking apps’ algorithms and/ or checking validation/evaluation of apps?
FDA: It depends on the risk of the device & patient exposure. With regards to functionality, it would be similar to other high risk development.
Q. Is there a time at which you hope to transition to another phase–one of enforcement and action?
FDA: We will allow reasonable time for app developers to be into compliance prior to enforcement actions.
Q. How long does app rev/approval typically take?
FDA: On average, it has taken 67 days for clearance but it depends on the complexity and functionality of the app.
Q. Approximately how many ‘clearances’ of apps are we talking about up till now?
FDA: The FDA has cleared about 100 mobile medical apps over the last 10 years
• For questions about a specific app, please email: firstname.lastname@example.org
• Health professionals & consumers may submit reports of mobile medical app adverse events or problems to FDA online & by phone @ 1-800-FDA-1088