The new article highlights the aspects related to certain specific cases when the review clock will stop due to the decisions taken by the authority.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the actions related to the submissions under 510(k) premarket notification framework in the context of FDA review clock. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to assist in interpreting provisions of the respective regulations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance.

The scope of the guidance covers, inter alia, the aspects related to requests for additional information, as well as the citations when the 510(k) is not required. 


Requests for Additional Information 

Under the general rule, the authority may issue requests for additional information (also referred to as “AI requests”), should it appear that the 510(k) submissions do not contain all the information the authority reasonably needs to complete its review and determine substantial equivalence (making an SE or NSE determination). As explained in the guidance, such requests will be provided in electronic form via email and will be accompanied by documents describing the deficiencies to be addressed. Once such a request is issued by the authority, the review clock will be placed on hold starting from the date of such request. The authority also mentions that it generally issues an AI requests when … believes the additional information needed from the submitted is not suitable for interactive review and/or cannot be provided within a reasonable timeframe (i.e., such that the review would be unduly delayed if the submission where not placed on hold). As further explained in the document, the said request constitutes an interim action that stops the review clock – the latter will resume once a complete response is received from the applicant. 


510(k) is Not Required 

The document further provides additional clarifications regarding the situations when 510(k) is not required. First of all, it is clearly stated that it is the manufacturer’s responsibility to determine whether a 510(k) submission is required based on the FD&C Act, medical device regulations, and FDA-issued guidance documents. In its turn, the authority provides additional recommendations and guidelines to be taken into consideration when making such a determination. 

According to the guidance, situations, when a 510(k) is not required, include, inter alia, the following ones:

  1. Not-a-Device Decision. By issuing a “not-a-device” letter, the authority notifies the applicant that the product subject to review does not meet the definition of a medical device and, consequently, is not subject to regulation under the medical devices framework. This is considered to be a final action, so the review clock will shut off. 
  2. Exempt from 510(k) Decision. The existing regulatory framework provides specific exemptions from premarket notification requirements set forth under section 510(k) of the FD&C Act. Should the device subject to review fall within the scope of such an exemption, the authority will issue an “exempt” letter or notify the applicant in another way that the product does not require a 510(k) submission. Currently, the exemptions are outlined in 21 CFR 807.20(c), 807.65, as well as individual classification regulations (21 CFR Parts 862-892). As in the case of a “not-a-device” decision, the “exemption” decision is a final action with shuts off the review clock.

Notice of Withdrawal 

Another important aspect addressed in the guidance relates to a notice of withdrawal by the virtue of which the authority notifies the applicant that the 510(k) submission is considered to be withdrawn. As further explained by the FDA, the notice of withdrawal represents an FDA decision to discontinue its review of the 510(k) submission because the submitter (applicant) failed to submit a timely and complete response to an AI request that placed the submission on hold. For instance, this could take place in case the applicant fails to provide additional information the authority has requested by issuing an AI request within the applicable timeframe, which is 30 days from the date such a request has been issued by the authority. Failure to provide a complete response within the said timeframe creates grounds for the authority to consider the application to be withdrawn. At the same time, the authority mentions that it has not strictly enforced this in the past, allowing the applicants to submit the information requested within the extended timeframe. Moreover, the authority is intended to follow this approach in the future, providing extensions of up to 180 calendar days from the date of the initial request. 

Once a notice of withdrawal is issued by the authority, the review clock will be stopped, so this action is consider final as well.

In summary, the present FDA guidance provides additional explanations regarding the impact different actions taken by the authority will have over the review clock. In particular, the document describes the situations when the product in question does not meet a definition of a medical device, falls within the scope of an exemption from 510(k) requirements or the application associated thereto is considered withdrawn due to the failure of the applicant to provide additional information requested by the authority within the respective timeframe. 



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