Innovation Pathway

Background on CDRH Innovation

On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices in a way that maintains or improves patient safety and is based on sound science.

As part of that Initiative, the FDA proposed the Innovation Pathway, a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery. The FDA also announced a pilot submission — a brain-controlled, upper-extremity prosthetic — for review under the Pathway.

After considering public comments received on the Innovation Initiative — and extensive review of our experience from the pilot submission, the FDA is introducing the Innovation Challenge, a call for voluntary submission of innovative device applications for End-Stage Renal Disease (ESRD).

Regulatory decisions that improve patient access to safe and effective,
 innovative medical devices

Developing a New Approach to Device Review
Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

Developing a New Approach to Device Review

Developing the Innovation Pathway is an evolving process that entails the FDA approaching medical device review using new paradigms — rapidly testing them, applying what works and learning from what doesn’t. A team of experts are analyzing each step of the premarket pathways for medical devices and exploring ways to bring about more patient-centric, predictable and swifter decisions that can also address the unique scientific challenges that innovative technology often brings. The team has begun developing new tools and processes, including:

• A decision-framing tool to help reviewers and sponsors quickly determine product classification and regulatory direction;
• A decision-framing tool to help reviewers and sponsors determine requirements for first-in-human clinical trials; and
• A collaborative workspace where FDA staff, medical device developers, patients, scientists and industry can discuss the technology, intended use and the unmet public health need.

These tools, and others in development, present the FDA with the opportunity to commit its time and resources much earlier in product development. By front-loading these resources, the FDA can identify and resolve new scientific and regulatory challenges that may accompany an emerging technology that raises new or novel scientific questions. As a result, patients will receive safe and effective products more quickly and device makers can bring important technologies to market more predictably, faster, and at a lower cost.

In order to use and evaluate the new tools and processes, the FDA is inviting innovators who have ideas for medical devices that diagnose or treat End-Stage Renal Disease (ESRD) to volunteer for our Innovation Challenge. When proven successful, the FDA plans to integrate these new approaches into its other premarket programs when applicable.

Additional Information

• Driving Biomedical Innovation: Initiatives for Improving Products for Patients
• Medical Device Innovation Initiative White Paper
• Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010/li>

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

In the Federal Register Notice the background information (the first few paragraphs of Section 3 [Overview] of the Guidance document) is interesting as follows:

“To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used.  Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) Device users, (2) device use environments, and (3) device user interfaces. This interaction and its possible results are depicted graphically in Figure 1.

Fig 1 From FDA Guidance Document - Interactions among HFE/UE considerations result in either safe & effective use or unsafe or ineffective use

For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction are safety-related and should be components of risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device, and avoid potential device recalls.

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To submit comments follow these instructions: Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

A proposal has been circulated, on 21-JAN-2011, for a vote to form a Joint Working Group between ISO/TC 184/SC 2, Robots and robotic devices (non-medical robots) and IEC/TC 62 and its subcommittees to establish a new Joint Working Group on Safety for medical devices using robotic technology.  The following info is only part of the complete proposal.  If you have further interest please contact Leo Eisner at Leo@EisnerSafety.com.

Some Background:

Currently published international standards only cover robots in industrial environments. However, the situation is changing and new types of service robots are emerging. In light of these developments, ISO/TC 184/SC2 established a new work group (WG 7) on personal care robots. That group has been focused on formulating safety requirement for non-medical personal care robots. That group is working on a new standard, ISO 13482, Robots and robotic devices – Safety requirements – Non-medical personal care robot. This document will be advancing to the Enquiry Stage (ISO DIS) in early 2011 and publication is expected in 2012.

While initially focused on non-medical applications, WG 7 recognized early that work was likely to be needed on medical devices utilizing robotic technology. In June 2008, a liaison with IEC/SC 62A was established. Prof. John Hedley-Whyte volunteered to serve as the liaison officer. In September 2009, ISO/TC 184/SC 2 established a WG 7 study group on medical care robots. The study group is comprised of experts from Canada, France, Germany, Japan, Korea, Romania, Switzerland, UK and USA. The Secretary of SC 62A has attended two of the study group’s meetings. Members of the study group also participated in a workshop on Medical Care Robots sponsored by the US Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and held at FDA’s offices outside Washington D.C. in February 2010.

The WG 7 study group has concluded that the time is appropriate to initiate formal work on safety standard(s) for medical devices using robotic technology. The study group made a series of proposals to ISO/TC 184/SC 2 that resulted in the resolution in Annex A (please contact Leo Eisner if you would like a copy of this Annex). The potential for a joint project between IEC/TC 62 and its subcommittees and ISO/TC 184/SC 2 was also discussed at the IEC/TC 62 Chairman Advisory Group meeting in October 2010 in Seattle.

The Proposal:

ISO/TC 184/SC 2 is proposing the formation of a JWG with IEC/SC 62A under IEC administrative lead to develop a new work item proposal for a Collateral Standard in the IEC 60601 family. The scope of this work would be:

Establish basic safety and essential performance requirements for medical electrical equipment and systems employing robotic technology (i.e., medical robots). The work would encompass medical applications (including aids for the disabled) covering invasive and non- invasive procedures such as surgery, rehabilitation therapy, imaging and other robots for medical diagnosis and treatment.

The current working definition of a robot is an “actuated mechanism programmable in more than one axis with a degree of autonomy, moving within its environment, to perform intended tasks”. Autonomy is currently defined as the “ability to control movement and communication to perform intended tasks without human intervention”. Before a meaningful new work item proposal can be circulated, the proposed JWG will need to refine these definitions so as to establish the appropriate boundaries for this work.

While the initial work would be with SC 62A dealing with the general aspects of medical robots, close liaison will be maintained with other TC 62 subcommittees, particularly SC 62D, looking forward to the potential for work on standards for particular medical robot applications.

If approved, it is expected that the experts currently serving on the study group would be transferred to the JWG and a New Call for Experts issued in IEC/SC 62A and ISO/TC 184/SC2.

National Committees are requested to provide their responses using the IEC electronic voting system by: 2011-04-22

So, if you would like to have some input to your National Committee you will need to contact them soon as national votes tend to be called for at least 1 month prior to the official deadline for the National Committees.

Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter

Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:

• IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
• Usability and Human Factors verification, validation, and regulatory requirements
• Clinical evaluation and investigation regulatory requirements

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG 

When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast

Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited

Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404

You can view the current & previous lists which shows all the Fed Reg publications of the Lists.  The best way to use this system of Recognized Standards List is to access the Database.

Later in the article there are Highlights of Proposed Changes to 510(k)

From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page:

“This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket FDA-2007-N-0270. Comments may include draft language on the proposed topics and/or suggestions for new or different guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments. This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.

Current FDA and CDRH guidance documents can be found on the CDRH Guidance Document page.”

Further along in the description of the process the FDA CDRH says this process is to “provide stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances.”

After talking with the FDA Oct 5 with one of the people that has written some of the draft guidances that will come out later this year he indicated that if the document comes out for public review & comment and there is no feedback that doesn’t make the document as good as it could be.  The FDA is really seeking feedback on the draft guidance documents to make them much better and to be useable by the stakeholders.

The webpage http://ht.ly/2OiXg where the CDRH is considering documents for FY11 has instructions on how to comment on these draft guidance documents.

Also, at the bottom of the webpage http://ht.ly/2OiXg there is a list of “What guidance document is CDRH considering for development during FY 2011?”  The list is over 40 items long and covers areas such as product specific, safety standards, medical device quality systems, guidance on postmarket and compliance issues, among other areas.  Below is a list of some of the draft guidance they hope to publish and get comments on in their FY 11.  Note that not all of these will make it out of FDA by the end of their FY11 (ends Sept 2011):

• Application of IEC 60601-1 Third Edition
• Medical Device ISO 13485
• Radio-Frequency Wireless Technology in Medical Devices
• Medical Device Appeals and Complaints: Guidance on Dispute Resolution
• Medical Devices Containing Materials from Animal Sources (except IVDs)
• Medical Device Home Use
• Medical Device Premarket Clinical Studies: Levels of Evidence
• Manufacturing Site Change Supplements: Content and Inspectional Considerations
• Medical Device Reporting for Manufacturers
• “510k Actions”‐FDA and Industry Actions on Premarket Notification Submissions
• Distinguishing Medical Device Enhancements from Product Recalls and Corrections
• Electronic Medical Device Reporting
• Computed Tomography
• Implantable Cardiovascular Defibrillators
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Pediatric Information in Diagnostic Medical Device Premarket Submissions