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requirements or an official policy, but rather was released by FDA to seek early input prior to the development of a draft guidance document.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 “an appropriate framework” for algorithms that learn and adapt in the real world. Continue Reading
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 passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).
- Legislative Background
The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.
On February 1, 2019, FDA issued a final guidance 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 new approach, manufacturers of certain device types would demonstrate substantial equivalence through FDA-established or FDA-recognized objective safety and performance-based criteria that reflect current technological principles. Instead of reviewing data from direct comparison testing between two devices, FDA would support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate devices.
The performance criteria for a specific device type may be described in FDA guidance, FDA-recognized consensus standards, and/or special controls. Use of performance criteria will only be appropriate when FDA determines that (1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; (2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device; and (3) the new device meets all the performance criteria.
FDA will detail the types of devices and the applicable performance criteria for the Safety and Performance Based Pathway in future guidance, and intends to maintain a list of device types appropriate for the pathway on the FDA website.
FDA described the alternative pathway as providing a less burdensome (but still robust) way to demonstrate substantial equivalence, and expressed hope that it would make review of 510(k) submissions more efficient, thereby reducing burdens on FDA and review times for individual submissions. Although direct comparison of a new device with a legally marketed device will remain available under a Traditional or Special 510(k) pathway, FDA’s long-term goal is for the Safety and Performance Based Pathway to become the primary framework for devices eligible for 510(k) review.
This newly issued guidance is just one part of FDA’s Medical Device Safety Action Plan, through which the Agency seeks to encourage medical device manufacturers toward reliance on robust performance criteria and more modern predicate devices. The Action Plan reflects FDA’s concern that older predicate devices might not closely reflect the modern technology embedded in new devices, or a current understanding of device benefits and risks.
Other components of the Medical Device Safety Action Plan are in progress. For example, FDA is currently accepting comments regarding its proposal to make public on its website which cleared devices demonstrated substantial equivalence to predicate devices that are more than 10 years old.
 The draft guidance, issued April 12, 2018, was titled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.” FDA said the changed title reflects the Agency’s focus on advancing improved safety and performance of new products.
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 special requirements for certain types of devices, including sterile, implantable, and in vitro diagnostic devices. The Draft Appendix sets out proposed special requirements for software that falls under the definition of medical device.
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 what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific. Continue Reading
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 therapeutic products, where scientifically appropriate.” The Draft Guidance is part of a broader agency focus on personalized medicine. Continue Reading
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. Continue Reading
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. Continue Reading
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 MAC announcements here and here). This recent shift is an important precedent for technologies that incorporate the use of electronic devices to display and share medical data, and may foreshadow flexibility in future federal policy development to support the important role smart devices are increasingly playing in communicating medical data. Continue Reading