December 16, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

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1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: December 16, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket No. FDA-2015-D-3787 Dear Sir/Madam: The Advanced Medical Technology Association (AdvaMed) provides these comments in response to a request regarding the Food and Drug Administration (FDA or Agency ) Center for Devices and Radiological Health draft guidance Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices. Notice of this draft guidance and request for comments was published in Fed. Reg. Vol.80, No. 211/Monday, November 2, AdvaMed is the world s largest association representing manufacturers of medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members range from the largest to the smallest medical technology innovators and companies. We welcome the opportunity to comment on this guidance and look forward to working with FDA to ensure the revised guidance meets the needs and expectations of both FDA and industry. AdvaMed is pleased that FDA has undertaken the effort to describe the types of information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. However, we do have suggestions for improving the effectiveness of the document in providing clear and useful information about the types of information. This draft guidance provides minimal information in its discussion of requirements. Specifically, we suggest that the guidance provide examples of the information that demonstrate the level of detail expected and in some cases, definitions of terms. Providing examples and definitions will help ensure the users of the guidance have a clear understanding of requirements. Also, the guidance states that manufacturers often reference IEC and the requirements listed appear to focus on the IEC requirements. Because the requirements for active implantable devices are not consistent with those described in IEC , we suggest that the guidance indicate when active implantable or other device specific requirements are acceptable. Attachment A provides specific comments on the draft guidance. These comments reference line numbers provided in the draft guidance text. Bringing innovation to patient care worldwide

2 Division of Dockets Management (HFA-305) December 16, 2015 Page 2 of 9 Docket No. FDA-2015-D-3787 In conclusion and as previously stated, AdvaMed supports the FDA efforts to provide guidance on the types of information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. We appreciate the efforts taken by FDA personnel in preparing this draft guidance and support the goals of developing a guidance that serves the mission of FDA, the needs of industry and the common goal of benefiting public health. Sincerely, /s/ Ruey C. Dempsey Vice President Technology & Regulatory

3 Line(s) No. Line number of the guidance on which you are commenting Change Proposed Change to the guidance. Reason Reason/Rationale for the proposed Change. General Comment The draft guidance is useful in describing the specific information that FDA expects for medical electric equipment (MEE) that is within the scope of IEC :2014, as most items listed have direct correlation to required elements of the test report required by that standard (i.e., Clause 9, Table 10). However, a consistent framework for active implantable devices which are tested to different consensus standards does not exist. In addition, some of the EMC information that FDA requests in Section II of the draft guidance (items A through I) is not necessarily applicable to active implants. For example, FDA-recognized device-specific EMC standards, ISO and ISO , have well-defined test limits and compliance criteria, and no further derivation of the test limits are necessary when testing to these standards. The standards continue evolving to stay current with upcoming technologies, and therefore additional EMC testing is not necessary. For instance, EMC standards for cardiac (pacemakers, implantable cardioverter/defibrillators and resynchronization) devices have a long history of development (going back to EN50061), provide well-established methods for testing EMC, and are very effective at assessing performance of implanted cardiac devices in the presence of electromagnetic interference. FDA has been, and continues to be, involved in the development of these standards. Therefore, demonstrating compliance to these implantable device standards with no additional EMC testing is expected to be sufficient. Page 3 of 9

4 General Comment Clarify in the scope that this guidance covers both performance and safety requirements, which should be treated distinctly and separately in the information provided to support EMC and safety statements. General Comment General Comment 64 Provide instructions on the use of FDA Form 3654 [510(k)s] in conjunction with this guidance for 510(k) submissions. Clarify within the document scope that it is not applicable to in vitro diagnostic devices. Add the following (in bold type) in a premarket submission (PMA, 510(k), de novo) It would be helpful to specify that Form 3654 should be included for 510(k) submissions or not. With the focus on IEC 60601, use of terminology, such as active medical devices, and lack of reference to applicable IVD equipment standards, the focus of the draft guidance appears to be on patient contacting devices, as opposed to non-patient contacting devices, such as in vitro diagnostic device laboratory equipment. Should the Agency include IVD laboratory equipment within the document scope, we recommend the Agency re-issue the document as a draft for comment to enable the IVD industry the opportunity to review and comment. Specify the types of submissions to which the guidance applies. 65 Define electrically-powered medical device. Reference 3.63 and 3.64 from IEC for definitions of medical electrical equipment and medical electrical systems. Reference ISO for the definition of Active Implantable Medical Device. If the guidance document is intended to address both medical electrical equipment (as defined in ) and active implantable medical devices, it would be useful to provide these definitions. Page 4 of 9

5 75-78 Replace the first sentence of paragraph three with: Manufacturers of electrically-powered medical devices often reference FDA-recognized consensus national or international standards for EMC in pre-market submissions. For medical electrical equipment or medical electrical systems (as defined in IEC ), the reference is made primarily to the International Electrotechnical Commission (IEC) standard or the equivalent United States (US) version 2. Provides clarity for the scope of IEC Propose changing text from: There are also other consensus standards for electricallypowered medical devices that include information on EMC [e.g., International Organization for Standardization (ISO) for active implantable devices]. to: There are also consensus standards for active implantable medical devices that include information on EMC. Some examples include International Organization for Standardization (ISO) for Implantable Neurostimulators and ISO for Implantable Cardiac devices. It is important to differentiate EMC requirement standards for medical instrumentation (IEC ) and active implantable medical devices (ISO & 14117). As written, the guidance document makes frequent reference to IEC , then parenthetically mentions one EMC standard for implantable neurostimulators. While the EMC information requested in Section II could be the same between medical instrumentation and active implantable devices, the EMC standards are different. Specifically the EMC standard for cardiac (pacemakers, implantable cardioverter/defibrillators and resynchronization) devices, which has a long history of development (going back to EN50061), provides well-established methods for assessing EMC, and continues evolving to address new environments. If the intention of the guidance document is to address only medical instrumentation (non-implantables), this should be made clear in the Introduction and Scope, and references to the implantable standards should be removed. Page 5 of 9

6 89 Add (in bold type) recognized versions of IEC and other standards. This statement should not be exclusive for IEC Industry and FDA staff should consult the database for all currently recognized standards information. 98 Consider splitting Section II into two parts to separately address expectations for 1) non-implantable device EMC (e.g., devices under the scope of IEC 60601) and, 2) implantable device EMC. Applicability of the Section II items (A-I) differs between active implants and non-implantable medical electrical equipment. For example, implantable device consensus standards ISO and ISO have well-defined test limits and no further derivation of the test limits are necessary for implantable devices. EMC results for these devices should therefore be accepted by FDA with no additional testing necessary. 103 Revise sentence to read (in bold type);..to support the EMC claim. The full test report is not required. Add specificity and make clear that the full test report is not required. Some reviewers currently ask for the test report from the testing house. 105 Clarify whether item B immunity test levels is intended to apply only where EMC testing results in a derivation of test levels. A declaration of the specifications of the standard that were met is reasonable, especially if a standard is applied in part. Immunity test levels are not derived for standardized EMC testing of active implants. The test levels are defined in the standard(s) and are self-evident where a full declaration of conformance is rendered. 107 Add in item C: "Specification of the environments defined by the manufacturer for normal operation, and for which safety (but not performance) is ensured. This includes the SPECIAL ENVIRONMENT, if applicable. The specification should be communicated to the Before discussing pass/fail criteria and tests, the environmental conditions must be specified in more detail. The environmental conditions can be determined using the IEC However the safety levels and not the normal environment is used. The levels shall be determined for Page 6 of 9

7 user, and this information to the user should be submitted as well. Note: The user information shall be such that he can take proper measures to make the environment suitable for the MEE. normal performance by the manufacturer Clarify applicability of item C to active implants. State if the manufacturer is expected to summarize the pass/fail criteria defined in the standard for each individual test clause, even though these criteria are applied uniformly. Pass/fail criteria are defined in active implant EMC standards and are not derived. 108 Add the following (bold type): the device-specific pass/fail criteria used (this includes how the pass/fail criteria were derived) 6, when not referenced in a standard. When the standard specifies pass/fail criteria it should not be necessary to specify why the criteria were used Clarify applicability of item D to active implants. It is not clear how to be responsive to this item for active implants, given its IEC origin. 111 Add the following to read (in bold type) was determined by the manufacturer to be. Clarify who has the responsibility for determining the essential performance of the device. 112 Provide examples of what information is required to meet the requirement to show these functions were monitored. The level of detail is not specified. Examples would be very helpful. Page 7 of 9

8 114 Add the following (in bold type): the summary of the device performance Make clear that it is not necessary to include raw data and each test result with the submission Clarify applicability of item E to active implants. It is not clear how to be responsive to this item for active implants, given its IEC origin. For example, active implant EMC testing to ISO (cardiac implants) is a combination of conducted and radiated tests with non-derived test levels prescribed. 117 Clarify the expectation for justification information. Replace justification with rationale. It is unclear why the submission needs to justify choosing an option allowed per the standard OR deviation from the standard per G. Rationale or context for using the allowance would be better terminology Clarify applicability of item F to active implants. It is not clear how to be responsive to this item for active implants, given its IEC origin. Active implant EMC standards do not incorporate allowances Clarify applicability of item I to active implants. It is not clear how to provide this information for active implants, given its IEC origin. Active implant EMC standards do not allow for changes or modifications that enable a passing result. Page 8 of 9

9 Add the following (in bold type): a detailed description of all changes or modifications that were made to the version of the device intended to be legally marketed in order to pass any of the EMC tests. If modifications were made that impact safety or essential performance, a statement. Further clarification is needed regarding at what point in the development process that all changes or modifications to the device are required to be detailed. This should only apply to the version of the device that the firm intends to legally market. Page 9 of 9