During the course of the last several months, there have been many regulatory shifts surrounding medical device development throughout the globe. NAMSA’s experts, working with various government entities and regulatory agencies, have observed various trends and insights that will be important for device manufacturers to consider over the course of 2017. Below, we highlight the top five predictions and what these could mean for the industry as a whole. (Information confirmed at time of publishing; many changes will be forthcoming.)
I. New U.S. President and New FDA Commissioner
A new U.S. President often results in a new Food & Drug Administration (FDA) Commissioner. The FDA’s most recent Commissioner, Dr. Robert Califf, recently stepped down from his post and many controversial names are now being considered for this position.
Prediction: Expect a new FDA Commissioner in 2017.
Currently, the names floating around for the FDA Commissioner post share close relations to the venture capital investment industry.
The possibility of Jim O’Neill as FDA Commissioner is a bit interesting, and is an unusual choice. He is not a physician, and lacks the strong science background that nearly all former Commissioners have had in recent years. In fact, O’Neill has stated that drugs should be on the market before their efficacy has been proven, as long as they are considered safe.
Another name currently being thrown in the hat is that of Dr. Scott Gottlieb, a former FDA Deputy Commissioner. Dr. Gottlieb is a venture capitalist with New Enterprise Associates. Regardless, Gottlieb seems to be a better fit considering his medical background and prior FDA experience.
Califf, who has only been on the job since February 2016, will likely leave a minimal imprint on the FDA, as he is too new to have much of a lasting impression. Although he has been identified as a “big data” advocate, it is not clear if either O’Neill or Gottlieb will endorse that position.
Regardless of the new Commissioner’s name or background, there is mounting pressure to get innovative health care products – drugs and devices – with improved timelines to market as quickly as possible. This pressure will, no doubt, disappear throughout 2017. (Reference)
II. Risk Management Process, Usability and Human Factors Engineering
Many view the risk management process as the most critical for successful product design and development. Implementation of a life cycle-based risk management process is a key requirement for any successful product development effort. From pre-market design inputs, to market clearance/approval with reasonable safety and effectiveness characteristics, to post-market clinical evaluations and surveillance reports, most agree this process cannot be overlooked.
Risk assessments are more than critical; they have proven to be a valuable project management tool to connect and prioritize development tasks and processes including human factors and usability engineering for novel and innovative life sciences products.
Many new FDA guidance documents have been released in 2016 that set expectations for risk assessment, including the importance of risk management and human factors/usability engineering for the medical device industry. Among the documents that have been released are the following:
Prediction: Risk management, including human factors/usability engineering, will continue to be a hot topic for FDA pre-market notifications and CE-mark submissions in 2017.
The new ISO 13485:2016 revision is extending the scope of risk management from a product development requirement to a risk management quality tool for supply chain processes and distributor relationships.
To strengthen this point, the FDA has released new guidance documents to communicate expectations and interconnectivity of risk management, human factors engineering and usability. (Reference)
III. ISO 13485:2016 Will be the New Quality System Management (QMS) Standard
2016 was a big year for ISO 13485. A revision to this standard was long overdue and published last March. There is a three year grace period to transition from ISO 13485:2003 to ISO 13485:2016. But, device firms should expect ISO 13485:2016 to begin to take hold in 2017 with Notified Bodies. In fact, several ISO audits being scheduled for companies in early 2017 by Notified Bodies have requested that the 2016 “upgrade” takes place as soon as possible.
But beware…device manufacturers cannot assume that their QMS is already in alignment with ISO 13485:2016 requirements. This new revision to the Quality Management Standard includes several changes:
- incorporation of risk-based approaches to safety and performance of the medical device and in continually meeting regulatory requirements beyond product realization;
- increased relationship with regulatory requirements, and in particular, regulatory documentation;
- harmonizing software validation for QMS applications for process and production control, including and monitoring and measurement equipment;
- emphasis on infrastructure for orderly handling, production of sterile medical devices and validation of sterile barrier properties;
- consideration in design and development of usability, use of standards, verification and validation planning, design transfer and design records;
- emphasis on complaints, reporting to regulatory authorities and consideration of post-market surveillance; and
- planning, documenting and implementing corrective and preventive action without undue delay.
Prediction: An increasing number of device manufacturers will conduct a thorough gap analysis with a concise action plan of current certified QMS processes against the new and revised QMS requirements in ISO 13485:2016.
IV. The EU Medical Device Regulations Have Arrived
The European Commission has long discussed and proposed changes that significantly affect the medical device industry in Europe. The European Medical Device Regulations (MDRs) are now awaiting translation and final ratification by the European Parliament in Brussels to become the new medical device jurisdiction for all European Member States.
Prediction: The EU will finalize and implement MDRs in the second quarter of 2017.
It is important to recognize the legal character of the MDR. The regulation is not a European Directive, having to be transposed and released into national law, but constitutes binding jurisdiction for all CE-marked devices approved for commercial distribution, and without national deviations.
The new MDR will definitively implement changes. Many are not completely new, but rather consist of harmonization of existing concepts of medical device approvals for all European medical device manufacturers.
Highlighted below are a few significant changes:
a. Transitioning Role and Tasks for Notified Bodies (NB)
NBs are no longer contracting partners that allow for collaboration with the medical device industry, but are becoming regulatory entities that are to implement and maintain a transparent regulatory framework for all medical devices in Europe, including enforcement tasks and extended authorities (e.g. unannounced inspections).
b. New or Different Clinical Evidence
New or different clinical evidence for all devices, specifically new clinical data requirements for high-risk devices, including all long-term implant devices and certain Class II devices, are as follows:
- significantly reduced equivalency evaluation options against legally marketed predicate devices;
- harmonization and scrutiny of investigational study designs and study endpoints; and
- continual and proactive updates of real-world clinical performance with mandatory follow-up summary reports to regulatory bodies and other stakeholders.
c. New and Different Labeling Requirements
New and different labeling requirements, such as that of a Unique Device Identifier (UDI) i.e. Unique Device Identifier (UDI), and periodically updated public statements of safety and clinical performance will be required. (Read our recent blog post on the updated labeling requirements here).
Prediction: Many Notified Bodies may not be able to maintain their accreditation for new European Medical Device Regulations. They will either limit their scope, or may even disappear completely. Skeptics even predict a significant reduction of remaining MDR accredited Notified Bodies in Europe.
These new regulations will have an impact on all medical devices sold in the European market. And, while there seems to be plenty of time to adjust and rethink, device firms should consider that these changes will not only impact new medical device products, but also existing products already CE-marked. (There will be no grandfathering!)
Device manufacturers should be aware that there is a transition period; the MDRs will go into full effect within three (3) years of adoption.
It is highly recommended to be pro-active and plan carefully ahead with your Notified Body for a successfully and timely transition. (Reference)
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February 8, 2017 (10-11 a.m. EST)
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V. New 510 (k) Guidance Documents Observation
In the U.S., the most common pathway to receive FDA market clearance for a medical device is a 510(k) submission. Well over 90 percent of all medical devices cleared to market utilize this regulatory pathway for commercial distribution in the US.
The fundamental principle of a U.S. FDA 510(k) market clearance is the substantial equivalency concept to an already cleared device with same intended use, similar principal design and mode of action.
While the 510(k) process is well established and defined, the FDA has been criticized for potential flaws and pitfalls of the 510(k) clearance process, such as:
- substantial equivalency comparison to technology that is outdated, but cleared medical devices;
- appropriateness of predicate device selection;
- communication of sufficient predicate information to allow for a reasonable evaluation of substantial equivalence;
- missing or inconclusive FDA guidance documents on safety and performance expectations;
- expectations on 510 (k) submissions needing a clinical investigation to establish clinical effectiveness; and
- addressing changes to cleared medical devices.
In order to improve the 510(k) clearance process, and to enhance patient safety and clinical effectiveness (as well as to provide predictable market access for most low- and medium-risk devices), the FDA has made an increased effort to release new FDA guidance documents.
The below table lists some of the most important guidance documents in 2016.
The most significant among the released documents are the guidance for proposed changes to a cleared device.
Under U.S. federal regulations, device manufacturers are required to submit a 510(k) application when a change to a device “could significantly affect the safety or effectiveness of the device,” or when there is a “major change or modification in the indented use of the device.” However, despite issuing guidance on the topic in 1997, the FDA says that further clarification is necessary in order to align industry and agency interpretations of these requirements.
The new guidance comes five years after the FDA’s controversial first attempt to replace its existing guidance (2011). However, the FDA withdrew the guidance after Congress ordered the agency to rethink its policies in light of strong industry opposition. At the time, industry felt that the 2011 draft guidance would significantly increase the number of reportable changes that would require a new 510(k) submission.
In the 73-page guidance, the FDA lays out its guiding principles of what can constitute a change requiring a 510(k) device modification. The guidance also includes five flow charts intended to help device manufacturers make a determinations for specific changes.
Consistent with its report to Congress, the FDA released a separate guidance detailing when changes to a medical device’s software might require a new 510(k) submission.
Prediction: Medical device manufacturers will monitor more closely these and other FDA medical device regulatory, and policy initiatives as they evolve. They may have an important effect on the overall regulation of medical devices in the U.S. and, in particular, and may provide more timely and less burdensome market clearance via the 510(k) process. (Reference)