Biomedical Engineering Reference
In-Depth Information
tion of FDA centers) for the individual components of a combination product.
Requiring the approval of a second FDA center for a product presents additional
issues, requirements and costs for the applicant.
The FDA has developed policies and procedures for the review and regulation
of combination products and in February 2002 established a Combination Prod-
ucts Program within the Office of the Ombudsman to coordinate such activities.
The Office of Combination Products also has assumed the functions of the
Combination Products Program begun in 2002 within the FDA Office of the
Ombudsman. The Office of Combination Products primary functions are: assign-
ing an FDA Center to have primary jurisdiction for review of combination
products; ensuring timely and effective premarket review of combination products
by overseeing reviews involving more than one agency center; ensuring consist-
ency and appropriateness of postmarket regulation of combination products;
resolving disputes regarding the timeliness of premarket review of combination
products; updating agreements; guidance documents or practices specific to the
assignment of combination products; submitting annual reports to Congress on the
Office of Combination Product activities and impact. In addition to serving as a
point of contact for industry and the FDA Centers (CDRH, CBER, CDER) on
combination products issues, the Office of Combination Products is developing
guidance documents on a variety of policy issues for combination products. The
FDA office of Combination Products was established by the Medical Device User
Fee and Modernization Act of 2002.
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7.4.2
Food and Drug Administration request for
designation for a combination product
Currently, combination products need to submit a 'request for designation' (RFD)
to the FDA Office of Combination Products. By submitting a RFD, a company
may obtain a formal agency determination on which FDA center they should work
with in developing a new combination product. A company may submit an RFD
for a combination product or for a drug, device, or biological product, when the
jurisdiction is unclear or in dispute. The agency will make its jurisdictional
determination no later than 60 days after filing the RFD. The RFD process is
outlined in 21 CFR Part 3.
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7.4.3
Food and Drug Administration marketing
applications of combination products
The FDA Safe Medical Device Act (SMDA)
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required that the primary mode of
action of a combination product must determine which FDA center would be
responsible for premarket review, but did not address which authorities, including
which type of marketing application, should be used to review the combination
product, beyond authorizing FDA to use any resources necessary to ensure an
