The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity.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 A draft guidance is in effect what the FDA is thinking about thinking.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
There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of private certifications, there is a growing need to evaluate them, judge their relative costs and benefits, and determine which – if any – are worth adopting as either the one certified or as the consumer of certified products or services.
These private activities are usually distinct from governmental requirements (e.g. FDA or FTC compliance, or state licensing), although in the case of EHR Meaningful Use (MU) certification, private entities function on behalf of the federal government to certify compliant EHRs. Note here that compliant EHRs are those that are capable of achieving MU. Purchasing a product that is thus certified is a prerequisite for a provider then achieving MU.Read More
The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials.
As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”. As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”Read More