Draft guidance issued on the use of voluntary consensus standards in the USA

Opportunity to comment on US FDA guidance for industry

The US FDA has issued draft guidance to its programme to recognise standards in support of medical devices regulation. Manufacturers can submit a declaration of conformity to a recognised standard to facilitate the review process to clear their devices. The FDA has approximately 1,200 standards developed nationally within the USA, internationally by ISO and IEC, or by another acknowledged standards development organization. The FDA has recognised that greater use of recognised standards can promote more efficient and consistent premarket review and facilitate market entry for safe and effective medical devices. The use of internationally-recognized standards can also reduce the burden on manufacturer from inconsistent standards being used by different jurisdictions.

The draft guidance document is titled “Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff”. When final, this document will supersede “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition,” issued on September 17, 2007.

The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing recognition of a standard. It describes the process for:

• recognizing voluntary consensus standards used for medical device declarations of conformity;
• determining complete or partial recognition of consensus standards and the criteria used in the process; and
• deciding not to recognize a consensus standard.

FDA recognizes standards by publication of a list in the Federal Register. This list is published at least annually. Once a standard is recognized, the online database for Recognized Consensus Standards is updated. The database includes a Supplemental Information Sheet for each decision. This Supplemental Information Sheet provides:

• title, scope and date of publication of the standard;
• date of the notice announcing the standard’s recognition;
• extent of recognition of the standard;
  • The extent of recognition can be “Complete Standard” for a standard recognized in its entirety or “Complete Standard with the following exceptions” for a standard recognized in part. In the case of partial recognition, the exceptions are listed by section or clause number sequentially, including the titles of the applicable section or clause numbers.
• examples of products for which the standard may be applicable;
• Product examples are typically not provided for horizontal standards, e.g., biocompatibility or sterilization standards, because maintaining a representative list would be impractical given the number of products covered

If it is decided not to recognize a standard because it does not satisfy or would not be helpful in satisfying regulatory requirements, the decision is posted on the Standards web page.

Recognition of a previously-recognized standard may be withdrawn if it is no longer appropriate for meeting a requirement regarding devices. This could be because:

• a new edition of the standard is issued, the new edition is recognized and the previous edition withdrawn; or
• the recognized standard is judged no longer appropriate for meeting a requirement regarding devices.

Remember that an adoption of an international standard by a country outside the USA may be identical to a standard recognized by FDA, e.g., ISO or IEC standards adopted as European Standards and published by BSI (BS/EN/ISO) or adopted directly as British Standards (BS/ISO). However, the FDA does not generally include these identical adoptions in their list of recognized standards.