The Food and Drug Administration (FDA) has published a document amending the list of consensus standards utilized in the review of premarket submissions.
Voluntary Consensus Standards Recognized by FDA
The 1997 Food and Drug Modernization Act introduced the procedure of consensus standards recognition. The term “recognition” means that any particular standard in question could be used by medical device manufacturers to declare conformity. According to this Act, a local regulating authority has the power to recognize standards developed by both national and international organizations that apply to medical devices.
Earlier in 2018 the FDA issued a detailed guidance describing many factors related to the use of consensus standards. Consensus standards are applicable to all 510(k) submissions, premarket approval applications, De Novo requests and other types of medical device-related applications and review procedures. The main goal of implementing consensus standards is to modify the assessment of medical devices for and clarify regulatory frameworks. This will assist medical device manufacturers in complying with the safety and effectiveness requirements pertaining to medical devices. If consensus standards are applied properly, the list of documents required would be reduced substantially, resulting in a decrease of the time necessary for the regulating authority to review the application. If the medical device complies with the particular voluntary consensus standard recognized by the FDA, it would be enough for a manufacturer to submit a Declaration of Conformity without providing additional confirmation on compliance with the requirements set forth in the standard. This approach allows the simplification of the procedures related to submission review.
It is important to mention that the use of consensus standards is not compulsory for medical device manufacturers if these standards are already implemented in applicable regulations. In that case, the standards are incorporated by reference, meaning that the regulation itself already includes the requirements set forth by the particular standard in question. In any case, the requirements laid down in the regulation will prevail. Even if the manufacturer declares conformity with one or several applicable standards, compliance with the standing regulations will be also necessary if such regulations provide additional requirements.
Changes to the List of Consensus Standards
The document published by the FDA provides information on changes to the list of recognized consensus standards, including additions, withdrawals and corrections. All changes are also reflected in the list of the Recognized Consensus Standards available through an online database. The document contains two parts:
- The list of standards withdrawn or replaced, and
- The list of standards added and recognized by FDA.
The standards in both lists are divided into groups depending on the particular sphere of application. This is done in order to simplify the process of searching for the standards that apply to the particular medical device in question. According to the tables, the amended voluntary consensus standards cover the following areas:
- Dental/Ear, Nose and Throat (ENT);
- General, including quality systems and risk management
- In Vitro Diagnostics;
- Materials used in medical devices;
- Sterility; and
- Tissue engineering.
It is important to notice that according to the applicable regulations, any person has a right to submit a recommendation on the voluntary consensus standard recognition, providing details on the standard to be recognized by the FDA. The regulating agency would look over and consider these submissions and add the standard mentioned to the list of recognized consensus standards if it was found reasonable.
Overview and Use of Voluntary Consensus Standards Application
According to the guidance, there are two ways to utilize consensus standards:
- Declaration of Conformity in accordance with the section 514(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act; and
- General Use.
To apply the voluntary consensus standards, a medical device manufacturer must perform the following steps:
- Check the recognition of the standard by the FDA. All consensus standards recognized by the FDA have a recognition number assigned in a special notice published in the Federal Register. These standards are also listed in the Recognized Consensus Standards online database. The information provided in the database includes both the recognition number and a Supplemental Information Sheet (SIS) containing additional information on each particular standard, even about the standards that are still under review. For instance, an SIS includes a list of medical device types associated with any given standard. It is important to mention that medical device manufacturers could also comply with the standards that the FDA decided to recognize before their official recognition release. Information on the standards that the FDA decided to recognize is also available in the online database.
- The Declaration of Conformity should contain the following information:
- The name and address of the manufacturer,
- Information on the medical device, including name, registration and identification numbers,
- Statement of conformity,
- A list of applicable standards with the FDA recognition numbers,
- Information on the date of registration, place and responsible person,
- All applicable limitations.
- Declarations of Conformity should be based on testing performed by the manufacturer itself or with the involvement of the third party (e.g. certification entity authorized to perform the appropriate testing). It is not required for the Declaration to contain the testing data, but such information could be requested by FDA during the application review procedure. The FDA recommends the inclusion of the test report to the submission. If the third party is involved in the testing process, it is also necessary to provide this information on accreditation of the third party.
When a medical device manufacturer complies with the recognized standard but for some reason decides not to file a Declaration of Conformity, this is considered general use of the consensus standard. “General Use” is also applicable if the manufacturer complies with standards that are not recognized by FDA or if there are certain deviations from the recognized consensus standard. If the particular medical device is not included in the scope of the standards outlined by the medical device manufacturer, it is necessary to provide the explanation describing the reasoning behind using the particular standard. According to recommendations issued by the FDA, testing should be performed using the “Finished device, that is, under the applicable regulations, the device that has all the features of the device that would be marketed, including packaging and sterilization (if it is necessary due to the device type)”. Testing can also occur using a version of the device that is not a final one, but in this case the manufacturer must provide detailed information on all the important safety and effectiveness changes between the two device versions.
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