Inside Medical Devices

Updates on developments for medical devices

In a recent post on the Covington Digital Health blog, we analyze FDA’s recently-released proposed regulatory approach for medical devices that use artificial intelligence (AI) and machine learning (ML), which we refer to here as the “AI Framework.” The AI Framework does not establish new requirements or an official policy, but rather was released by FDA to seek early input prior to the development of a draft guidance document. The AI Framework is FDA’s attempt to develop…
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being…
On February 1, 2019, FDA issued a final guidance[1] establishing an optional 510(k) pathway for certain well understood devices. This “Safety and Performance Based Pathway,” an expansion of the longstanding Abbreviated 510(k) program, is part of FDA’s ongoing effort to modernize and strengthen the 510(k) program. The pathway will continue to require the identification of predicate devices for the intended use and technological characteristics decision points of the substantial equivalence analysis. But under the…
On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of devices regardless of whether they are imported or made in China.  Subsequently, NMPA added various appendices (fulu) to articulate…
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine…
On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued the Draft Guidance in an effort to “make it easier to get class labeling on diagnostic tests for oncology…
On October 3, 2018, the Centers for Medicare & Medicaid Services (CMS) announced a number of changes to the local coverage determination (LCD) process. The new guidelines are outlined in a revamped Chapter 13 – Local Coverage Determinations – of the Medicare Program Integrity Manual (PIM). This manual chapter had been the subject of criticism, with some stakeholders arguing that a lack of transparency potentially denies patient access to innovative treatments.…
In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification Program, is meant to encourage the development of health and medical software, including potentially software using artificial intelligence.…
On August 17, 2018, FDA announced that it finalized its Voluntary Malfunction Summary Reporting Program (“Program”).  The Program is intended to reflect the goals for streamlining manufacturer malfunction reporting that FDA and industry agreed to in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter.  The finalized Program is based on positive findings from a 2015 pilot program and public comments submitted to a 2017 Federal Register proposal.…
The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as Medicare Administrative Contractors (MACs), modified their policies in part to recognize “the use of smart devices (watch, smartphone, tablet, laptop computer, etc.)” (see CMS and…