The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a final rule on “intended use” of medicines and medical devices. The appropriate notice has been published in the Federal Register. The present rule amends current regulations on the matter with regard to the scope of information necessary to determine whether a product in question should be subject to regulation under the medicines or medical devices framework accordingly.
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The aforementioned framework includes:
- The Federal Food, Drug, and Cosmetic (FD&C) Act;
- The Public Health Service (PHS Act); and
- FDA’s implementing regulations.
The new rule described herein enters into force on September 1, 2021.
New Final Rule: Key Points
According to the official notice published in the Federal Register, the new rule announced by the FDA is intended to introduce a new approach to evaluating whether a product is intended for use as a drug or device, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. The authority also states that certain changes have been made to the proposed rule, but the core aspects remain intact. In particular, in response to comments received, the FDA clarifies that the new rule should be applied in the context of medical devices that are approved for marketing and use in the US or exempted from premarket notification. The Agency expects that the new rule will improve the existing regulatory framework by making it more transparent and clear for all the parties involved. At the same time, it is not expected to impact in any way the expenses incurred by the parties who already have their products placed on the market.
First, the notice provides the definitions of the most important terms and concepts used in the context of “intended use” of medical products, including the following:
- Medical products – drugs and devices, including human biological products.
- Medical use that is approved, cleared, granted marketing authorization, or exempted from premarket notification – an intended use included in the indications for use statement for a device cleared or granted marketing authorization by FDA, or an intended use of a device that falls within an exemption from premarket notification.
- Products unapproved for any medical use – those that are not approved, cleared, granted marketing authorization, or exempted from premarket notification by FDA for any medical use, and which must be approved, cleared, granted marketing authorization, or exempted from premarket notification to be legally marketed for such use.
According to the document, the proposed rule dedicated to the matter was initially issued in 2015 and was intended to enter into force in 2017. However, it has not become effective due to regulatory concerns. Then the FDA announced new public consultations and proposed a new rule later in 2020. The present final rule is mostly based on the proposed rules published in 2020.
The Agency states it has received numerous comments and suggestions during the consultation period – approximately 15 comments were submitted by the stakeholders involved in operations with drugs and medical devices, including industry representatives and other parties involved. These comments express certain concerns regarding the legal nature of the new rule and its applicability to specific types of medical devices – for example, those falling within the scope of 510(k) exemption. The present official notice published by the FDA provides responses to those comments that contained specific concerns regarding the proposed rule and how it should be applied. The Agency also states that the general comments without specific issues raised were not addressed in the notice. All comments and responses thereto are divided into groups depending on the underlying regulatory matters.
Comments and Responses Regarding Definitions
One of the comments was a request to provide definitions and additional clarifications with regard to such terms as “intended use” and “indications for use.” In particular, it was suggested to use the appropriate definitions provided in other guidance documents issued by the Agency. Additionally, it was stated that such terms are mostly used in the context of medical devices, while their use with regard to drugs remains unclear.
In response, the Agency stated that existing regulations dedicated to the intended use actually address any and all medical products, including both drugs and medical devices. Moreover, it was stated that the term “indications for use” does not appear in regulations at all. Hence, it should not be defined. The questions regarding substantial equivalence raised in some of the comments fall outside the scope of the present rule and are not addressed by the FDA accordingly.
Another important regulatory matter raised in the comments relates to the concept of “approved or cleared medical products.” In particular, it was stated that current regulations do not explicitly mention the products placed on the market under the appropriate exemption since such products do not require any prior approval or clearance. Thus, it was suggested for the FDA to amend regulations accordingly in order to include such products as well. Additionally, it was requested to provide additional clarifications regarding the difference between labeling requirements for drugs and medical devices.
In its response, the regulating authority agreed to amend the wording in order to include products placed on the market under special exemption. In particular, §801.4 was supplemented with the phrase “granted marketing authorization, or exempt from premarket notification.” With regard to the question on the difference between labeling requirements, the Agency responded that it is not covered by the scope of the present final rule and thus would not be clarified herein.
There was also a request to provide the definitions of such terms as “unapproved new use for an approved or cleared” and “unapproved use of an approved product” in codified legislation since, as of now, there is a certain inconsistency in the use of such products.
In order to assist medical device manufacturers and other parties involved in operations with medical devices, the Agency has included the definitions of the aforementioned concepts in the preamble to the regulation. At the same time, it was stated that the authority does not find it necessary to introduce such definitions on the legislative level.
The Agency was also asked to expand the scope of the term “healthcare providers” to include laboratories as well. In responses, the FDA stated that the term “healthcare provider” includes a non-exhaustive list of individuals who are licensed or otherwise authorized by the State to prescribe, order, administer, or use medical products in a professional capacity. Consequently, the scope of this term already includes individuals performing certain functions in laboratories.
In summary, the official notice published in the Federal Register describes the new final rule related to the intended uses for drugs and medical devices. Additionally, the notice highlights the most important comments received by the authority and its responses.
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