Inspections, Compliance, Enforcement, and Criminal Investigations

Page 6

 

GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
QUALITY SYSTEMS


2. restrictions of use of the device; and 3. justification for any immunity levels that are lower than the standard's general immunitytest levels, as well as any actions that need to be taken by a user or installer as a result.

In addition, the PMA or 510(k) may have required specific EMC labeling.

Investigators should collect copies of any questionable labeling for review by CDRH.

PURCHASING CONTROLS

21 CFR 820.50(a) Evaluation of suppliers, contractors, and consultants

All purchased or otherwise received products and services must conform to specified requirements (specifications). Since design verification for EMC will often be done by type-testing at a contract laboratory, purchasing controls apply to that contractual arrangement. The device manufacturer may require that the product meet certain safety requirements, such as those specified in IEC 60601-1-2, or some other standard. When adherence to such a standard is specified, the FDA investigator should identify which standard and what sections of the standard the product is intended to be in conformity with, and then review the finished device manufacturer's product specifications as provided to the vendor, as well as the documentation (if any) provided by the vendor to the device manufacturer for verification of conformity.

Manufacturers of finished devices should clearly convey to a vendor the specified requirements for the product to be procured from the vendor, including the quality, functional, and safety characteristics for the product. When the product supplied by the vendor is itself an electrical component (e.g., shielded cables, filters, circuit boards), and/or will be used in or with an electronic medical device (i.e., an accessory), the finished device manufacturer should provide the vendor with the EMC requirements for that product. This includes:

  1. product electrical specifications, such as the type of cable or electrical parameters of a component or filler material,
  2. any testing requirements, such as use of an anechoic chamber or GTEM cell or specific EMD frequency ranges or distance of the signal from the device,
  3. shipping and storage requirements (if necessary),
  4. testing documentation (if performed), and
  5. documentation to be supplied to the medical device manufacturer (e.g., certificates of analysis, certificates of conformance, raw test results, etc.)

21 CFR 820.50(b) Purchasing Data

Manufacturers are encouraged to have a written agreement with the vendor for advanced notification of any changes to vendor manufacturing, product design, or testing prior to implementation. If the vendor is unwilling to enter into such agreement, the finished device manufacturer should demonstrate that an effort was made, and demonstrate how their receiving inspection department is capable of identifying product that is changed in some manner affecting EMC prior to acceptance and use.

INSPECTION, MEASURING & TEST EQUIPMENT

21 CFR 820.72(a) Control of Inspection, Measuring, and Test Equipment

For the finished medical device manufacturer who produces electronic devices, the role of inspection, measuring and test equipment, calibration, and calibration standards during the various phases of production is significant. Such equipment could range from a simple volt-ohm meter to a complex computer-controlled radiation detector. Therefore, it is very important that the manufacturer select, design (where appropriate), and operate this equipment in a manner which both prevents any damage to the medical device, and accurately detects adherence or non-adherence to electrical or EMC specifications for the device.

Routine inspection and calibration (where

 

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Page Last Updated: 11/25/2014
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