Voluntary consensus standards are developed by national and international bodies and contain precise criteria that are meant to be used as guidelines in the development of products and processes.
Some examples of these standard bodies in the medical device industry include:
- American Society for Testing and Materials (ASTM)
- International Organization for Standardization (ISO)
- International Electrotechnical Commission (IEC)
Voluntary consensus standards are important to consider in terms of the priorities of the target market for the device and 510k or PMA or DENOVO Submission.
Below is a statement from the AAOS that highlights reasons why medical device developers should be concerned with voluntary consensus standards:
FDA recognized voluntary consensus standards.
FDA recognizes that voluntary consensus standards can be a valuable resource for the medical device industry and its stakeholders.
The use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. Consensus standards helps to provide certain aspects to evaluate safety and effectiveness of the device, such as acceptance criteria, testing methods, and risk management and usability.
An updated guidance document on the appropriate use of voluntary consensus standards was issued by FDA in 2018, which outlines five attributes that consensus standards should meet to gain CDRH recognition
- Openness to all interested parties during the standard’s development processes and procedures.
- Balance in the 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 the development of standard.
- The appeals process in place for impartially addressing procedural appeals.
- Consensus in terms of general agreement among stakeholders regarding the standard’s final iteration.
FDA provides a public database where we can find all standards:
Requests for new or changes to existing consensus standards can be made to FDA for their assessment of whether it can be added to their recognized list. You can initiate a request by navigating to the “Submitting a Request for Recognition” subsection of FDA’s Standards and Conformity Assessment Program page.
Once FDA has assessed a request to recognize a consensus standard, it will issue a decision letter. This may be a determination to grant full recognition, partial recognition, or non-recognition.
This determination is based upon scientific, technical, or regulatory criteria. If the ruling is for partial recognition, FDA will identify which components of a standard are not recognized.
Appropriate use of voluntary consensus standards.
As the term “voluntary” implies, consensus standards are not mandatory for medical device premarket submissions to FDA. This states that manufacturer may choose to use appropriate consensus standards, or address issues relevant to approval and clearance in another manner.
Consensus standards only satisfies a portion of a premarket submission. Manufacturer needs to provide additional information to prove the safety and effectiveness of the medical device.
FDA provides two appropriate ways for manufacturers to use consensus standards in 510k premarket submissions:
- Through the declaration of conformity in accordance with section 514(c)(1)(b) of the FD & C Act.
- Through general use of consensus standards.
Declaration of conformity
The purpose of a declaration of conformity is to acknowledge or demonstrate conformance with an FDA recognized standard that assists sponcers in meeting FDA 510k premarket submission requirements. This helps to reduce the amount of supporting data and information submitters required to submit.
FDA expects that all necessary testing required by the consensus standard will be performed and conformance to the consensus standard will be met prior to the premarket submission. If sponsor is using a consensus standard with his/her submission, they need to submit a Declaration of Conformity that meets FDA’s criteria.
The elements of a Declaration of Conformity are listed below:
- Name and address of the applicant/sponsor responsible for the DOC
- Product/device identification, including product codes, device marketing name, model number and any other unique product identification data specific to the DOC in question.
- Statement of conformity
- A list of standards for which the DOC applies including, for each standard, the options selected, if any
- The FDA recognition number for each standard
- The date and place of issuance of the DOC
- Signature, printed name, and function of the sponsor responsible for the DOC.
- Any limitation on the validity of the DOC (e.g., how long the declaration is valid, what was tested, or concessions made about the testing outcomes).
It’s important to note that the device type is not included within the scope of that standard, submitter must explain why that consensus standard is appropriate for their device.
General use of consensus standards
General use refers to situations where you might choose to conform to a consensus standard either in part or in whole, but without submitting a Declaration of Conformity.
There are many potential reasons for not submitting a Declaration of Conformity, but some of the most common include:
- The manufacturer has simply chosen not to submit a DOC.
- The manufacturer has made deviations from the consensus standard methodology relative to what the FDA has already recognized.
- The manufacturer has chosen to use a consensus standard that is not yet recognized. They might do this if there is no recognized standard yet for the device type.
If submitter are citing general use of consensus standards, FDA recommends that to include the basis of such use, including underlying information or data to support the use of the standard.
