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US Regulators Update Policies for Medical Device Voluntary Consensus Standards

Regulatory Updates | Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity.
  • The guidance describes FDA’s process and criteria for determining complete or partial recognition or non-recognition of consensus standards.

The US Food and Drug Administration’s medical device regulatory division has issued new guidance clarifying how it recognizes and withdraws voluntary consensus standards.

FDA’s Center for Devices and Radiological Health (CDRH) has published draft guidance to explain how the regulator evaluates whether to recognize voluntary consensus standards for use in medical device declarations of conformity, as well as whether to withdraw recognition of a standard.

Any volunteer consensus standard worthy of consideration for CDRH recognition should meet five attributes, according to the guidance:

  • Openness to all interested parties during standard’s development processes and procedures;
  • Balance in standard’s development process in terms of input from a broad range of stakeholders;
  • Due process in terms of documented, transparent and publicly available policies and procedures during development of standard;
  • Appeals process in place for impartially addressing procedural appeals;
  • Consensus in terms of general agreement among stakeholders regarding standard’s final iteration.

All CDRH-recognized consensus standards are published in the US Federal Register and entered into FDA’s Recognized Consensus Standards online database.

Requirements for requesting recognitions

Requests to FDA by interested parties for standard recognition should provide basic information including title, reference number and date of a standard; a list of medical devices for which declarations of conformity to that standard would apply; and related information regarding scientific and regulatory bases for recognition, testing and performance issues.

Recognition request outcomes

Once CDRH’s Standards Program staff receives a request for recognition of a consensus standard, the center will determine whether to grant complete or partial recognition, or non-recognition based on applicable scientific, technical and/or regulatory criteria. In cases of partial recognition, CDRH will identify which components of a standard are not recognized.

FDA has set  60-calendar-day timeframe for determining recognition, partial recognition or non-recognition of requests once received by the agency.

Withdrawing recognition

Finally, the new guidance explains FDA’s process for withdrawing recognition of consensus standards that no longer meets a device-related requirement. There are two scenarios that warrant withdrawal of a standard:

  • The Standards Development Organization (SDO) publishes a new or revised edition of the standard in question
  • FDA determines that the standard in question is no longer appropriate to meet a device-related requirement for any other reason

Additional US FDA medical device regulatory information:

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