The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, allows the manufacturers to use national and international voluntary consensus standards when preparing and evaluating premarket submissions for medical devices.
In order to assist medical device manufacturers in using consensus standards, the FDA has issued appropriate guidance describing the most important aspects to be considered when making references to the voluntary consensus standards in the course of applying for marketing authorization. At the same time, it is important to mention that due to its legal nature, the FDA guidance does not set forth any mandatory requirements the manufacturer shall follow, it only provides recommendations instead, allowing to use an alternative approach proving that such approach complies with the applicable requirements.
The scope of the FDA guidance covers the standards included in the FDA Recognised Consensus Standards Database Web site.
The Agency emphasizes the importance of voluntary consensus standards for simplifying the premarket application review process and increasing its predictability. In particular, consensus standards are being used to implement a unified approach to the most important aspects associated with the safety and effectiveness of medical devices, including:
- testing methods,
- acceptance criteria,
- risk management and usability.
Besides the aforementioned, the implementation of the consensus standards is a part of the international harmonization of the regulatory approach, which makes it easier for foreign medical device manufacturers to enter the US market.
The FDA guidance on voluntary consensus standards also describes the applicable laws and regulations, namely:
- The National Technology Transfer and Advancement Act (NTTAA) – a codified act establishing the principles and approaches to be used by the state agencies with regard to the voluntary consensus standards. The document also describes the exemptions – specific cases when the consensus standards should not be applied.
- The Food and Drug Administration Modernization Act and 21st Century Cures Act, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act). In particular, the document provides that the FDA shall recognize national or international standards to be applied in the course of the premarket review process. According to the FD&C Act, by «recognizing» the voluntary consensus standard, the FDA explicitly allows medical device manufacturers to make references to the appropriate consensus standard to demonstrate compliance with the safety and effectiveness requirements when applying for premarket authorization. In order to be recognized, the consensus standard should be added to the Federal Register.
According to the guidance, the manufacturers may refer to the voluntary consensus standards in the context of the following frameworks:
- Any 510(k) notifications, including Abbreviated Premarket Notifications (510(k)s),
- De Novo requests,
- Investigational Device Exemption (IDE) application,
- Premarket Approval (PMA) application,
- Product Development Protocol (PDP),
- Humanitarian Device Exemption (HDE) application,
- Investigational New Drug (IND) application,
- Biologics License Application (BLA).
At the same time, the Agency states that references to the consensus standards could cover only part of the requirements. Thus, the manufacturer submitting the application would still need to provide the full set of documents required for the particular type of submission in order to demonstrate compliance with the applicable requirements.
Thus, the FDA guidance on voluntary consensus standards describes the way both FDA-recognized and non-recognized standards should be applied when filing premarket submissions and also clarifies the way the Agency will use the appropriate standards during the submission review. At the same time, the scope of the guidance does not cover the cases when consensus standards are used to fulfill other requirements (not related to the premarket submission), as well as consensus standards incorporated by reference.
Application of US Consensus Standards
In particular, the FDA guidance provides medical device manufacturers with the additional recommendations regarding the content of a Declaration of Conformity (DOC) and also regarding the application of voluntary consensus standards in cases when the DOC is not required.
First of all, the Agency emphasizes that the use of consensus standards for medical device pre-market submission is not mandatory, except the cases when the appropriate standard is incorporated in the regulation by reference. Thus, the manufacturer may either refer to the applicable consensus standard or demonstrate compliance with the applicable requirements in another way. However, the reference to the consensus standard made by the manufacturer would not be a base for the regulatory decision itself – the manufacturer would still have to provide additional information and documents. At the same time, consensus standards could be used to demonstrate compliance with the specific requirements related to safety or effectiveness of the device, or substantial equivalence, in order to reduce the regulatory burden and the scope of the document to be provided.
According to FDA guidance, there are two ways the medical device manufacturer may use consensus standards in the context of the pre-market submission process:
- Declaration of Conformity in accordance with section 514(c)(1)(B) of the FD&C Act. In this scenario, the manufacturer shall submit a Declaration of Conformity containing references to the FDA-recognized standards (including the indication of an appropriate recognition number assigned by the Agency). Such standards are included in the Federal Register (except ones still waiting for the publication). When determining the applicability of the particular standard, the medical device manufacturer shall check the online database operated by the FDA. The database contains full and up-to-date information about the voluntary consensus standards that have been already approved for use by the FDA, as well as ones still pending recognition. The information the database contains includes the recognition number, assigned to each standard, and a Supplemental Information Sheet (SIS). By referring to the particular consensus standard in a Declaration of Conformity, the manufacturer explicitly confirms that the medical device in question meets any and all applicable requirements set forth therein, while any deviations from the standard are not allowed.
- General use of consensus standards. The medical device manufacturer may also refer to the consensus standard, in part or in whole, but do not file a Declaration of Conformity. Other situations when the manufacturer shall not submit a DOC include the deviations from the FDA-recognized consensus standards or references made to the standards that have not been recognized by the Agency.
Voluntary Consensus Standards: Use of Declaration of Conformity
According to the FDA guidance, the manufacturer may refer to the FDA recognized consensus standards (or ones the Agency intends to recognize) in order to reduce the scope of documentation to be provided to the FDA in the context of the premarket submission to simplify and accelerate the review. In this case, the Agency will assess whether the submission complies with the requirements set forth by the consensus standard the manufacturer refers to, while the manufacturer shall achieve and sustain compliance with any and all requirements set forth therein.
If the type the medical device in question belongs to actually falls outside the scope of the voluntary consensus standard the manufacturer refers to, the FDA will require the manufacturer to justify the grounds for such reference.
Another important aspect relates to the testing required under the consensus standards. The Agency emphasizes the importance of performing such testing using a final finished device to ensure that the device that would be actually placed on the market meets the applicable requirements.
Summarizing the information provided here above, a voluntary consensus standards framework allows medical device manufacturers to apply for premarket approval to reduce significantly the regulatory burden by making references to the consensus standards recognized by the FDA in order to avoid unnecessary expenses and simplify regulatory procedures in general.
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