The Food and Drug Authority (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the regulatory procedures related to requests for information as prescribed by Section 513(g) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

The latest version of the document was issued in December 2019 and constitutes a revised version of the same guidance issued previously in December 2015. The guidance provides non-binding clarifications and recommendations on the matter, which should be taken into consideration by medical device manufacturers and other parties involved in operations with medical devices intended to be marketed and used in the US.

The approach described in this document is one of several optional pathways recommended by the Agency. An interested party may apply another approach, provided such an approach complies with the respective regulatory requirements and has been approved by the authority in advance.

Regulatory Background 

According to the FDA, the document is intended to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513(g) of the FD&C Act, 21 USC 360c(g). 

As prescribed by the aforementioned regulation, all medical devices intended to be marketed in the US could be divided into three classes depending on the applicable regulatory controls reasonably necessary to ensure such devices meet any and all safety and performance requirements, namely:

  •  Class I, which requires only general controls;
  • Class II, which requires special controls as well; and
  • Class III, under which medical devices should be subject to premarket approval, together with the general controls. 

The determination of class under the applicable risk-based classification could also be performed on the basis of the classification of a similar medical device already placed on the market (predicate) by demonstrating substantial equivalence. In such a case, a medical device initially assigned to Class III could be reclassified as Class I or Class II, provided sufficient justification is in place. 

In particular, such an approach could be applied in the following cases:

  • The medical device has been found to be substantially equivalent to a medical device of the same type already classified as a Class I or Class II medical device;
  • The device is within a type of pre-amendments device which is to be classified under section 513(b) of the FD&C Act and FDA has found the device to be SE to a device within such type (an unclassified device type); or
  • FDA has classified or reclassified the device type in class I or II in accordance with sections 513(f)(2) or 513(f)(3) of the FD&C Act. 

According to the guidance, medical devices should be classified by generic type, which, for the purpose of the guidance, stands for a grouping of devices that do not differ significantly in purpose, design, materials, energy, source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness. In this regard, the authority has already issued a special regulation dedicated to the classification of medical devices that have been initially placed on the market prior to May 28, 1976. 

Obtaining Information About a Device

As stated by the Agency, an interested party may obtain additional information about the proper classification of the device regulatory requirements to be applied with regard to the particular device type through different options. For instance, one can use the information placed on special web resources operated by the FDA. In this way, an interested party can get additional clarifications and recommendations regarding the approach to be applied when determining the class of a new medical device under the applicable risk-based classification. However, if the necessary information cannot be found on the aforementioned resources, an interested party is also entitled to request additional clarifications directly from the authority by contacting the appropriate division of the Center for Devices and Radiological Health (CDRH).

According to section 513(g) of the FD&C Act, an interested party may submit a written request regarding the proper classification of a medical device and regulatory requirements applicable thereto. It is stated that the authority will provide a response for such a request within sixty days from the date it was received. It is important to mention that written requests related to regulatory matters other than classification and applicable regulations fall outside the scope of the aforementioned section 513(g) of the FD&C Act. Should be product in question be found by the Agency to be one that doesn’t meet the definition of a medical device as set forth by the applicable legislation, the Agency will notify the interested party accordingly. 

In particular, the response the Agency will provide will contain the following information:

  • The position of the authority regarding the proper classification of the medical device in question, based on the information initially provided by an interested party;
  • An indication of the class of devices within that generic type;
  • The reference to the particular regulatory pathway to be used when applying for marketing approval (e.g., a PMA or 510(k) premarket notification) depending on the class of the device;
  • Other requirements to be considered due to the class of the device;
  • References to the relevant guidance issued by the authority on the matter;
  • References to the device-specific requirements the authority may apply. 

However, the authority will not review data related to the safety and performance of the medical device in question or its SE to medical devices already placed on the market. The authority additionally emphasizes that such a response provided by the FDA should not be construed as a final determination of classification. In order to obtain a binding classification determination, an interested party shall submit an appropriate request under another framework – usually, it is a premarket notification submitted as prescribed by section 510(k) of the FD&C Act. 

Moreover, the response provided by the FDA in accordance with the procedure described herein will not indicate the particular types of testing to be carried out in order to collect evidence required to support the submission. In order to obtain such clarifications, an interested party shall file a Q-submission in accordance with the applicable procedure. 

In summary, the present guidance describes the approach to be applied to get additional clarifications and recommendations regarding the classification of devices of the same type and applicable regulatory requirements. The document provides details regarding how the request should be submitted, the information required, and the appropriate response will contain. 


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