The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD).
The document is intended to provide medical device manufacturers and other parties interested in placing their healthcare products on the US market with additional clarification and recommendations to be considered when applying for marketing approval. The latest version of the document was issued in April 2011.
Please note that due to its legal nature, the FDA guidance itself does not introduce any rules or requirements the parties involved should follow. Moreover, an alternative approach could be applied, provided that it complies with applicable regulatory requirements and has been approved by the Agency in advance.
Regulatory Background
The present FDA guidance outlines the scope of information an interested party (an applicant) should include in a Request for Designation. In other words, the document indicates the information reasonably necessary to the Agency to determine the regulatory status of the product in question and decide on the regulatory framework and requirements to be applied.
Later this determination and classification will be used to assign the product in question to the appropriate Agency for further review. According to the document, the principles described therein are based on regulation 21 CFR Part 3 with amendments introduced by the final rule for the primary mode of action of a combination product (PMOA Final Rule).
RFD for Non-Combination and Combination Products
In accordance with the definition provided in the Food, Drugs, and Cosmetics (FD&C) Act, the US core regulation in the sphere of healthcare products, a non-combination product is a product that is only either a drug, a device, or a biological product as each is defined in the FD&C Act. The definition of a “device” is provided by Section 201(h) of the FD&C Act.
Another important concept to be applied in the context of healthcare products intended to be placed on the US market is the concept of a combination product. In accordance with the applicable regulation, the definition of a combination product includes:
1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
4. Any investigational drug, device, or biological product packaged separately that, according to its proposed labeling, is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
The present FDA guidance also provides a reference to further information about combination products already published by the Agency, including the examples thereof.
Request for Designation – Key Points
A request for Designation (also referred to as a letter of request) is a written submission by the virtue of which an applicant requests the determination of:
1. The regulatory status of the product, and
2. The particular division of the Agency responsible for further review of the application (the particular Agency Center which will have primary jurisdiction – in case of a combination product).
A letter of designation (also referred to as a designation letter) stands for the formal response of the regulating authority and provides a binding determination covering aspects related to classification and/or center assignment. However, it is also important to mention that, in certain cases, the determination issued by the FDA could be changed under the appropriate procedure set forth by applicable legislation.
The Agency states that an applicant is not required to submit a Request for Designation with regard to any and all products it intends to place on the market. This mechanism is intended to be used in case the regulatory status of a new product is unclear, and an applicant has reasonable doubts with regard to the particular regulatory framework to be applied. In such a case, a request for designation should be submitted as soon as an applicant has the information sufficient for the FDA to make a determination.
The FDA additionally emphasizes that the Request for Designation should be submitted before filing any investigational or marketing application for the product … this will avoid a potential stay of the review clock if the classification or assignment of the product under review is determined to be unclear or in dispute during the review process. The Agency mentions that such an approach applied by the applicant will also allow the latter to save time and resources and facilitate the regulatory procedures related to the submission review in general.
It is also important to mention that in case an applicant has certain doubts with regard to the correct classification or assignment of several related products, the Requests for Designation should be submitted for each product separately.
Additional Aspects Related to RFD
The present FDA guidance also highlights additional important aspects to be considered by the applicant intending to submit a Request for Designation. For instance, it is mentioned that the applicant is not required to have a meeting with the representatives of the regulating authority before submitting a Request for Designation. At the same time, the FDA encourages contacting the regulating authority in advance in order to clarify all important aspects related to the information to be included in a Request for Designation or to determine whether an RFD request should be submitted with regard to the particular product in question.
Usually, the information contained in the Request for Designation is sufficient for the Agency to determine the regulatory status of the product and assign it to the appropriate division for further review. At the same time, an applicant could also appoint an additional meeting to describe in detail how the product in question operates and to provide additional information and clarification that could be important for the Agency when making a determination. For this purpose, an applicant could submit a request for a meeting and indicate the particular aspects to be discussed therein.
In summary, the present FDA guidance on writing a Request for Designation provides an overview of the RFD framework, including the request’s intended purpose and the most important aspects associated thereto. The document also provides additional clarifications with regard to certain types of products, including combination products, as well as the regulatory requirements to be applied.
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