To sign up for this Zoom conversation click here. This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.

Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015.

Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 (or 3rd edition + Amendment 1) which is the Canadian National Standard CAN/CSA C22.2 No. 60601-1:14 (issued in 2014).  It includes some Canadian National Deviations in the standard.  To find out more detail about this standard please refer to a blog post  I wrote back in 2014 on the topic.  The IEC 60601-1:2012-Ed.3.1 was also added to this Listing.

Several other changes of significance to the list of Recognized Standards for Medical Devices include.  This is a partial list of changes so refer to the list for more details:

1. The addition of the previous version of IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. For those that subscribe to the Eisner Safety Consultants Standards Reconnaissance Database you would know that the current version of IEC 60601-1-11 was updated in 2015.  This version of the standard is not on the Health Canada List of Recognized Standards for Medical Devices as of yet.
2. The removal of ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.  This standard has a replacement which was placed on the list previously which is ISO 80601-2-61:2011-Ed.1.0, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.  In the Foreword of the ISO 80601-2-61:2011 it says “This first edition of ISO 80601-2-61 cancels and replaces the second edition of ISO 9919:2005, which has been revised to harmonize it with the third edition of IEC 60601-1:2005.” So, the ISO 9919 standard has now been replaced by ISO 80601-2-61.  To find out more details about this standard in regard to the FDA & Health Canada Recognized Standards Lists you may want consider subscribing to the Eisner Safety Consultants Standards Reconnaissance Database.  We provide you with the FDA & Health Canada information about each standard that is in the database.  This way you don’t have to search an extra databases as this information is all in one place for each standard.  
3. The list added another older standard IEC 62366:2007 Medical devices – Application of usability engineering to medical devices.  The more recent version is IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices.  The Foreword of the most recent standard indicates “This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).”  The summary of changes noted here is part of the information we provide in each of the current versions of the standards for our paid subscribers for the Eisner Safety Consultants Standards Reconnaissance Database
4. The Canadian and the International versions of IEC 60601-1, 2nd edition have been removed from the list including: CSA C22.2 NO. 601.1 M90 (R2006) Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990) and IEC 60601-1:1988-Ed.2.0 Medical electrical equipment – Part 1: General requirements for basic safety + IEC 60601-1/Amd.1:1991 + IEC 60601-1/Amd.2:1995 + IEC 60601-1/Cor.1:1995.

These are just some of the changes that are of importance.  The below listings shows the August 31, 2015 Additions, Updates, and Removals to the Health Canada List of Recognized Standards for Medical Devices.  When there are updates to Regulatory Lists of Standards we will update the Eisner Safety Consultants Standards Reconnaissance Database listing as soon as possible so you are kept up to date on the changes to the standards of that specific Regulator. Currently we are monintoring the list of standards for FDA & Health Canada.  In the near future we will be adding in the European List of Harmonized Standards to this monitoring process.

Below are the 3 parts of the Health Canada list that have changed:

The Additions to the list of Recognized Standards include the following:

• ISO 5840-3:2013 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
• ISO 14117:2012-Ed.1.0 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
• IEC 60601-1:2012-Ed.3.1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• CAN/CSA-C22.2 NO. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-11:2010-Ed. 1.0 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-2-57:2011-Ed.1.0 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
• ISO 13408-1:2008 Aseptic processing of health care products – Part 1: General requirements
• ISO 13408-2:2003 Aseptic processing of health care products – Part 2: Filtration
• ISO 13408-3:2006 Aseptic processing of health care products – Part 3: Lyophilization
• ISO 13408-4:2005 Aseptic processing of health care products – Part 4: Clean-in-place technologies
• ISO 13408-5:2006 Aseptic processing of health care products – Part 5: Sterilization in place
• ISO 13408-6:2005 Aseptic processing of health care products – Part 6: Isolator systems
• ISO 13408-7:2012 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
• ISO 14644-1:1999 Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness
• ISO 14644-2:2000 Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
• ISO 14644-3:2005 Cleanrooms and associated controlled environments – Part 3: Test methods
• ISO 14644-4:2001 Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up
• ISO 14644-5:2004 Cleanrooms and associated controlled environments – Part 5: Operations
• ISO 14644-6:2007 Cleanrooms and associated controlled environments – Part 6: Vocabulary
• ISO 14644-7:2004 Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
• ISO 14644-8:2012 Cleanrooms and associated controlled environments – Part 8: Classification of air cleanliness by chemical concentration (ACC)
• ISO 14644-9:2012 Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration
• ISO 14644-10:2013 Cleanrooms and associated controlled environments – Part 10: Classification of surface cleanliness by chemical concentration
• ISO 14698-1:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
• ISO 14698-2:2003 Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data
• ASTM F2028-14 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

The Updates to the list of Recognized Standards include the following:

• ISO 14708-2:2012 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
• IEC 60601-2-24:2012-Ed.2.0 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
  Note: Additional accuracy testing results for flow rates below 1 mL/h may be required depending on the pump’s intended use
• IEC 60825-1:2014-Ed.3.0 Safety of laser products – Part 1: Equipment classification and requirements
• CSA Z900.1-12 Cells tissues, and organs for transplantation: General requirements
• ASTM F1160-14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• ASTM F1377-13 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
• ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• ASTM F2943-14 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

The Removals to the list of Recognized Standards include the following:

• ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
• ISO 21647:2004 Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors
  ISO 21647/Cor.1:2005
• ANSI/AAMI DF80:2003 Medical electrical equipment – Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)
• ANSI/AAMI PC69:2000 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
• ANSI/AAMI PC69:2007 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
  ANSI/AAMI PC69/ERTA:2008
• CSA C22.2 NO. 601.1 M90 (R2006)
  Medical electrical equipment – Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990)
• CSA C22.2 NO. 60601-1-2A-03 (R2006)
  Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)
• IEC 60601-1:1988-Ed.2.0
  Medical electrical equipment – Part 1: General requirements for basic safety
  IEC 60601-1/Amd.1:1991
  IEC 60601-1/Amd.2:1995
  IEC 60601-1/Cor.1:1995
• IEC 60601-1-2:2004-Ed.2.1
  Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard – Electromagnetic compatibility – Requirements and tests
• IEC 60601-1-4:2000-Ed.1.1
  Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
• IEC 60601-1-6:2006-Ed.2.0
  Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
• IEC 60601-2-10:1987-Ed.1.0
  Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
  IEC 60601-2-10/Cor.1:1987
  IEC 60601-2-10/Amd.1:2001
• IEC 60601-2-25:1993-Ed.1.0
  Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs
  IEC 60601-2-25/Amd.1:1999
• IEC 60601-2-26:2002-Ed.2.0
  Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs
• IEC 60601-2-36:1997-Ed.1.0
  Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
• IEC 60601-2-47:2001-Ed.1.0
  Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• IEC 60601-2-51:2003-Ed.1.0
  Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

If you need help withCAN/CSA C22.2 No. 60601-1:14 or IEC 60601-1, 3rd edition or edition 3.1 or you are interested in the Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

White Paper on The growing role of human factors and usability engineering for medical devices

This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.”  It is written by Bob North, Human Centered Strategies.

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series 

This is the last planned white paper in this series of white papers.  BSI said of the series that “…we are…producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The other white papers in the series you may be interested in reading, as they are very timely and current, are below:

• Negotiating the innovation and regulatory conundrum
• Engaging stakeholders in the home medical device market
• What you need to know about the FDA’s UDI system final rule
• Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up
• The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market
• Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance

You can sign-up for future white papers or sign-up for their industry sectors newsletter.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

As you know Risk management is a necessary, yet onerous, task when developing electro-medical devices. Since IEC 60601-1 3rd ed. was published, manufacturers have faced many new risk management challenges with respect to their electro-medical devices, especially home health devices.

Avoid the common pitfalls of risk management in IEC 60601-1 3rd ed. Experts will share case studies in their risk management practices for their own devices.

Come join us at the RAPS Convergence Conference to learn more on this subject.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.

The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the interpretation and implementation of the requirements related to the medical devices sector (MDD, AIMDD & IVDD).  The CMC has issued decisions that need to be considered and implemented by medical device manufacturers.You can find the decisions at http://www.cmc-md.eu/decisions.html.  Four decisions have been issued to date:

1.     Classification and Boderline Queries (23FEB2011) – States classification decisions along with rationales for:

– Wound irrigation solutions containing antimicrobial agents (Class III under rule 13)
– System to determine bacterial contamination in blood products (falls under the IVDD)
– Qualification of Gallipots as medical devices (not a medical device)

2.     Notified Body Best Practice Guides (23FEB2011) – This does NOT affect manufacturers.  It lists the Notified Body Operations Group (NBOG) Best Practice Guides (NBP) and states that all notified bodies are expected to follow these best practices.

3.     Address of the Manufacturer and EU Representative (issued 23Feb2011, updated 7JUN2011) – The ‘address of the manufacturer’ as required in the Essential Requirements on the labels and instruction for use, is the address of the registered place of business of the legally responsible manufacturer and shall include:

– street/road,
– number/house/floor,
– postal code
– city
– state/region and
– country

The same details have to be provided for the address of the authorized representative.
NOTE:  This is more extensive that what the FDA typically requires for an address.

4.     Readability of Instructions for Use (14MAR2012) – It must be assured, that patients and professionals may use the devices as intended by the manufacturer and any ambiguities with regard to the proper and safe use due to deficiencies in the readability of IFUs are avoided.  To that end:

a.     Appropriate checks should be performed by the manufacturer on suitable samples of target users whether IFUs are  really readable and assure proper and safe use of the device.  This includes consideration of font size, quality of translations, and understandability of texts and graphics.
b.     Post-market surveillance procedures have to be sensitive to any indications of bad readability via vigilance or other channels and to any necessary corrective measures.
c.     Special care has to be taken to enable users to properly identify changes to the previous version of the IFU on the basis of a risk assessment.

As dates/revisions are not posted with the document titles, it may be difficult to determine at-a-glance if the decisions have been updated.  Please take care when checking for updates that you inspect the document of interest.

Notified Bodies have been asked to audit these particular points.  You should anticipate that some or all of these issues will be reviewed during your next audit.

If you have any questions on this matter please feel free to contact us at Leo@EisnerSafety.com.

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.

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.

…”

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.

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