On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories are, by necessity, short and can’t cover all the issues but this one from iHealthBeat provides a good summary.
The final report (links to all draft documents) was submitted September 4, 2013 and was basically unchanged from the preliminary report.
The question to be answered by the workgroup was how to regulate HIT. I think we’re past the question of whether or not HIT should be regulated: there have been reports of patient deaths starting in 2005 (here and here), and that’s with almost zero reporting requirements on the part of providers or vendors, and the proliferation of HIT vendor non-disclosure and hold harmless agreements to supress reporting (see reports here and here).
The report, also called the “Section 618 report” for the section of FDASIA that mandates the workgroup and their report, is extremely concise and to the point – perhaps too concise for those outside the world of regulated medical devices. Of the three entities, FDA, ONC and FCC that are the focus of the report, by far the most focus was on the FDA. ONC and FCC received minor recommendations. This blog post focuses on the FDA issues and recommendations. You will have to read the workgroup’s recommendations yourself to pick up the specifics regarding ONC and FCC.Read More
A bit more than two years after releasing their draft guidance, FDA has released the final guidance (pdf) on mobile medical apps (FDA press release). FDA also put up a new page on their web site with information on mobile medical apps.
In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:
- to be used as an accessory to a regulated medical device; or
- to transform a mobile platform into a regulated medical device.
As always with FDA, the question of whether a mobile app is regulated or not, will be decided on the intended use or claims made by the manufacturer as described in promotional materials, user manuals and similar content and communications.
FDA references two pages of examples of mobile medical apps. The first list includes Class II medical devices that have received premarket clearance (aka, a 510k). Anyone can submit a 510k for clearance for any kind of device – whether FDA really thinks its a medical device or not. Consequently, this list is not an absolute guide to what FDA considers a mobile medical app that they want to regulate. Unfortunately, the page does not include any links to product information or information on the 510k summary for each product. A search on the “K number” in the FDA’s 510k database, e.g., K020866 for Abbott’s Freestyle Tracker Diabetes Management System, will return a 510k summary for the product, including intended use, classification and product code.Read More
On August 6, 2013, FDA published modifications to the list of medical device related standards they recognize. News was made of the fact that additions to the recognized standards addressed areas such as cybersecurity and interoperability. While there were many revisions and some additions of a variety of standards, this blog post will focus on the news making standards related to medical device connectivity.
The published modifications are divided between two separate recognition lists, number 31 (pdf) and 32 (pdf). Here is the Federal Register version (PDF). Recognition list number 31 includes one standard under the Software/Informatics category: Laboratory Automation: Data Content for Specimen Identification; Approved Standard (NCCLS AUTO-7A). The 20+ standards listed in recognition list number 32 are all new additions under Software/Informatics and focus on the following topics:
- IT governance in hospitals for networked medical devices,
- Medical device connectivity and interoperability, and
These are all great standards (although they are of varying relevance and usefulness). So where is the confusion, you might ask?Read More
On August 14, 2013, AAMI reports that the FDA has, “issued a new guidance document on integrating RF technology into medical devices.” You can read the FDA blog post on this guidance here. The draft version of this guidance on RF wireless medical devices was published more than 6 years ago in 2007 (blog post here). At the time, I thought the draft guidance was not earth shattering but a solid example of the application of the Quality System regulation to wireless medical devices.
In order to effectively use this guidance, or the earlier draft guidance, one must have a working understanding of wireless technologies and the FDA’s Quality System regulations. Only then is there sufficient context to be able to properly apply the guidance to the design, manufacture, installation and support of wireless medical devices. Like many initial connectivity efforts, dealing with these wireless issues can be a case of not knowing what you don’t know.Read More
On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the fate of many drafts. The two years that this draft has been out probably qualifies as an extended period. However the FDA did tell Congress, and the public, that the guidance would be released by the end of this fiscal year. Outsiders cannot tell if the appropriate FDA people are hard at work on this item, or if they are distracted in part by other issues. The FDA’s claimed devotion to transparency does not include being able to see how such things are progressing.Read More
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity. This guidance targets individual medical devices rather than the network they may be resident on, and it also includes non-networked devices. The FDA notes that both networking capability and portable media increase vulnerability. The latter issue might be called intermittent or remote connectivity.
Guidance documents tell interested people what the FDA’s current thinking is relevant to its regulatory authority, in this case the review of 510(k), PMA and related submissions. A draft guidance is in effect what the FDA is thinking about thinking. Drafts go through a comment period (90 days in this case) after which the FDA contemplates the comments and, after an unspecified time, either issues a guidance document, issues a revised draft, withdraws the draft, or just lets it sit there. Since guidance documents are not requirements, there is standard language that you can use an alternate approach if you can justify it. An open question for me is whether even a draft sufficiently establishes an FDA expectation that should be followed in the interest of a smooth submission review.There are many draft guidances currently under comment or post-comment review, including the long awaited guidance on medical apps discussed here.Read More