{"id":1591,"date":"2013-03-28T17:04:56","date_gmt":"2013-03-28T17:04:56","guid":{"rendered":"http:\/\/ncjolt.org\/?p=1591"},"modified":"2020-06-04T20:54:02","modified_gmt":"2020-06-04T20:54:02","slug":"i-do-not-recall-if-medical-device-enhancements-are-better","status":"publish","type":"post","link":"https:\/\/journals.law.unc.edu\/ncjolt\/blogs\/i-do-not-recall-if-medical-device-enhancements-are-better\/","title":{"rendered":"I Do Not Recall If Medical Device Enhancements Are Better"},"content":{"rendered":"

Friday, March 8, 2013, by Justin Mann
\nIf a manufacturer wants to change the color of its implantable cardioverter-defibrillator, finding that patients like blue more during product demonstrations, what kind of change is this considered?\u00a0 What needs to be reported to the FDA? \u00a0To the public?\u00a0 What if that same manufacturer finds a supplier with batteries that last twice as long as those used in the device\u2019s original Premarket Approval<\/a>?\u00a0 The Center for Devices and Radiological Health<\/a> (CDRH) at the FDA has taken a crack at answering these questions late last month when it issued a draft guidance document: \u201cDistinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements<\/a>\u201d (Docket ID: FDA-2013-D-0114).\u00a0 The Guidance walks us through the FDA\u2019s thought process for distinguishing between product recalls and product enhancements.\u00a0 After spending more than half of the document on this distinction, the FDA leaves you feeling unfulfilled by not explaining what you should do with this information.
\nTo begin the analysis, we are only talking about marketed devices, and the \u201cchanges\u201d captured by the classification, called \u201ccorrections,\u201d are anything you would generally consider a change (\u201crepair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device<\/a>\u201d).\u00a0 If you are making a change to a marketed device, you need to ask yourself four questions about the device:\u00a0 1) Is it failing to meet specifications (e.g., battery supposed to last 5 years, but failing after 4 years)?\u00a0 2) Is it failing to perform as intended (e.g., not engaging in certain situations)?\u00a0 3) Is its labeling \u201cfalse, misleading, or otherwise inaccurate<\/a>\u201d (e.g., labeling says the device is not affected by vigorous exercise, but a software adjustment is necessary for this to always be true)?\u00a0 4) Is it otherwise in violation of an FDA regulation?\u00a0 If you answer \u201cyes\u201d to any of the questions, then the change is a recall.\u00a0 If you answer \u201cno\u201d to all<\/span> of these questions, then the change is a product enhancement.
\nThe problem with the Guidance is that once you have put in the work of figuring out how to classify your change, it tells you nothing about what that means: \u201c[t]his guidance does not attempt to address all regulatory obligations associated with a change to a marketed device.<\/a>\u201d\u00a0 It does describe the reporting requirements for 21 C.F.R. 806<\/a>, but the analysis is identical for both types of changes! (If the change was to correct a \u201crisk to health<\/a>,\u201d then report.\u00a0 If not, then no reporting requirement.)\u00a0 Having been responsible for FDA reporting compliance in the past, I would prefer to see a table or flow chart that lists the regulatory obligations associated with a product recall versus a product enhancement.\u00a0 Considering the term \u201cproduct enhancement\u201d does not appear in FDA\u2019s regulations, at the very least, they should list the regulations that are pertinent to this type of change.\u00a0 As one commentator reminds us, fully understanding the regulatory requirements of a change are important because even errors in 806 reporting can have criminal and civil implications<\/a> under misbranding provisions.<\/p>\n","protected":false},"excerpt":{"rendered":"

Friday, March 8, 2013, by Justin Mann If a manufacturer wants to change the color of its implantable cardioverter-defibrillator, finding that patients like blue more during product demonstrations, what kind of change is this considered?\u00a0 What needs to be reported to the FDA? \u00a0To the public?\u00a0 What if that same manufacturer finds a supplier with …<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[51],"tags":[],"_links":{"self":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1591"}],"collection":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/comments?post=1591"}],"version-history":[{"count":1,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1591\/revisions"}],"predecessor-version":[{"id":7607,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1591\/revisions\/7607"}],"wp:attachment":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/media?parent=1591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/categories?post=1591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/tags?post=1591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}