A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo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).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

It would be great to meet you at this workshop or the entire conference and learn something new at the same time.  (See end of post for discount info)

Allison Komiyama, a former FDA reviewer, will be sharing an actual 510(k) that was redacted with us. This will give us a great perspective from the reviewer viewpoint and show us what types of comments and requests for additional information are made.

Robert Packard, a regulatory and quality systems consultant, with lots of 510(k) experience, will be sharing some of his insights into putting a 510(k) together and will focus on several of the more important sections of the 510(k).  He is currently asking for feedback which areas to focus on and you can send him an rob@13485cert.com with your suggestions too.  His current plan is to discuss:

1. provide an overview of the submission requirements with some focus on 510(k) format and contents (Section 2), 
2. review of Indications for Use (Section 4), 
3. review of 510(k) Summary (Section 5), 
4. review of Device Description (Section 11), 
5. review of Substantial Equivalence (Section 12), 
6. review of Performance Testing (Sections 18-20)

From the EMC experts I work with I have heard that some of the test levels have changed significantly and so that will could impact your designs for future compliance testing.  So, a question that is currently unanswered is when will this standard be transitioned into national standards for different countries around the world.  The standard text suggests at least a three year transition period.  It will be up to the different national standards development organizations (SDO’s) and the regulatory bodies around the world to make those determinations.  We will be keeping close tabs on this and reporting any information we hear more.

The foreword of the standard mentions a list of most significant changes from the third edition to the current fourth edition of the standard which include:

– specification of IMMUNITY TEST LEVELS according to the environments of INTENDED USE, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the HOME HEALTHCARE ENVIRONMENT and SPECIAL ENVIRONMENTS;

– specification of tests and test levels to improve the safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS when PORTABLE RF communications equipment is used closer to the MEDICAL ELECTRICAL EQUIPMENT than was recommended based on the IMMUNITY TEST LEVELS that were specified in the third edition;

– specification of IMMUNITY tests and IMMUNITY TEST LEVELS according to the PORTS of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM;

– specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE, resulting in some IMMUNITY TEST LEVELS that are higher than in the previous edition; and

– better harmonization with the RISK concepts of BASIC SAFETY and ESSENTIAL PERFORMANCE, including deletion of the defined term “life-supporting”;

and the following additions:

– guidance for determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS;

– guidance for adjustment of IMMUNITY TEST LEVELS when special considerations of mitigations or INTENDED USE are applicable;

– guidance on RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES; and

– guidance on identification of IMMUNITY pass/fail criteria.

We will send out a more detailed post on this topic in the future.  Keep an eye out for an update post on this standard.