Chapter 4: Jurisdiction and Regulatory Pathway
36
The Pre-RFD program was the result of FDA
enhancing transparency and consistency of the
informal, flexible process. FDA introduced How
to Prepare a Pre-Request for Designation (Pre-
RFD): Guidance for Industry, dated February
2018, to provide clear recommendations to
sponsors and applicants on how to submit a
Pre-RFD.19
The Pre-RFD process provides an informal,
non-binding preliminary assessment regard-
ing the regulatory identity or classification of a
medical product as either a drug, device, biologic,
or combination product. The Pre-RFD process
also provides information on the non-combina-
tion or combination product’s assignment to an
appropriate FDA center. There are similarities
and differences between the Pre-RFD and RFD
process (see Table 4-1).
The main similarities between the two pro-
cesses are the basic information provided, such as
a product description, proposed use or indication,
and a description of how the product achieves
its intended therapeutic/diagnostic effects. The
most striking differences between the Pre-RFD
and RFD are the length of the submission and
the depth of the regulatory analysis required. A
Pre-RFD does not have a page limit. Of course,
the sponsor or applicant should strive to provide
a succinct summary of all required information
in the Pre-RFD but will not be penalized for a
lengthier application. Regarding the regulatory
analysis, in the RFD, a sponsor or applicant must
provide an analysis of the product’ classification,
PMOA, and a recommendation for the center
with jurisdiction. This information is optional in
the Pre-RFD. OCP will still conduct a PMOA
analysis but will not have the sponsor or appli-
cant’s recommendation. A Pre-RFD should
contain the following basic information:
• Contact information, including sponsor
or applicant name, company’s name, email
address, and telephone number.
• A complete description of the product and,
if applicable, the following information:
o 510(k), Premarket Approval (PMA), New
Drug Approval (NDA), Abbreviated New
Drug Approval (ANDA), Biologics License
Application (BLA), or any other FDA reg-
ulatory submission number associated with
the product.
o Name of the product and all component
products.
o A photo/diagram of the product.
• For products sourced from biologically
derived materials, a description of how the
Table 4-1. RFD and Pre-RFD Comparisona
Submission Type RFD
(Information Required)
Pre-RFD
(Information Recommended)
Description of product Yes Yes
Proposed use or indications for use Yes Yes
Description of the manufacturing
processes, including the sources of all
components
Yes Optional (if available recommended if it is a
human cell, tissue, or cellular- or tissue-based
product (HCT/P) or a biological product)
Supportive data/studies Yes Optional (if available)
Description of how a product achieves its
intended therapeutic/diagnostic effects
Yes Yes
Analysis of classification, primary mode
of action (PMOA), if it is a combination
product, and jurisdictional assignment
Yes Optional (if available)
Description of related products Yes Optional (if available)
Sponsor recommendation Yes Optional (if available)
Page limit Yes No
a. How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry. February 2018. Final. FDA website.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designa-
tion-pre-rfd. Accessed 19 March 2021.
36
The Pre-RFD program was the result of FDA
enhancing transparency and consistency of the
informal, flexible process. FDA introduced How
to Prepare a Pre-Request for Designation (Pre-
RFD): Guidance for Industry, dated February
2018, to provide clear recommendations to
sponsors and applicants on how to submit a
Pre-RFD.19
The Pre-RFD process provides an informal,
non-binding preliminary assessment regard-
ing the regulatory identity or classification of a
medical product as either a drug, device, biologic,
or combination product. The Pre-RFD process
also provides information on the non-combina-
tion or combination product’s assignment to an
appropriate FDA center. There are similarities
and differences between the Pre-RFD and RFD
process (see Table 4-1).
The main similarities between the two pro-
cesses are the basic information provided, such as
a product description, proposed use or indication,
and a description of how the product achieves
its intended therapeutic/diagnostic effects. The
most striking differences between the Pre-RFD
and RFD are the length of the submission and
the depth of the regulatory analysis required. A
Pre-RFD does not have a page limit. Of course,
the sponsor or applicant should strive to provide
a succinct summary of all required information
in the Pre-RFD but will not be penalized for a
lengthier application. Regarding the regulatory
analysis, in the RFD, a sponsor or applicant must
provide an analysis of the product’ classification,
PMOA, and a recommendation for the center
with jurisdiction. This information is optional in
the Pre-RFD. OCP will still conduct a PMOA
analysis but will not have the sponsor or appli-
cant’s recommendation. A Pre-RFD should
contain the following basic information:
• Contact information, including sponsor
or applicant name, company’s name, email
address, and telephone number.
• A complete description of the product and,
if applicable, the following information:
o 510(k), Premarket Approval (PMA), New
Drug Approval (NDA), Abbreviated New
Drug Approval (ANDA), Biologics License
Application (BLA), or any other FDA reg-
ulatory submission number associated with
the product.
o Name of the product and all component
products.
o A photo/diagram of the product.
• For products sourced from biologically
derived materials, a description of how the
Table 4-1. RFD and Pre-RFD Comparisona
Submission Type RFD
(Information Required)
Pre-RFD
(Information Recommended)
Description of product Yes Yes
Proposed use or indications for use Yes Yes
Description of the manufacturing
processes, including the sources of all
components
Yes Optional (if available recommended if it is a
human cell, tissue, or cellular- or tissue-based
product (HCT/P) or a biological product)
Supportive data/studies Yes Optional (if available)
Description of how a product achieves its
intended therapeutic/diagnostic effects
Yes Yes
Analysis of classification, primary mode
of action (PMOA), if it is a combination
product, and jurisdictional assignment
Yes Optional (if available)
Description of related products Yes Optional (if available)
Sponsor recommendation Yes Optional (if available)
Page limit Yes No
a. How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry. February 2018. Final. FDA website.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designa-
tion-pre-rfd. Accessed 19 March 2021.