Exemptions and consideration for certain drugs, devices, and biological products
A meeting under clause (i) may—
address the standards and requirements for market approval or clearance of the combination product;
address other issues relevant to such combination product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and
identify elements under subclauses (I) and (II) that may be more appropriate for discussion and agreement with the Secretary at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.
The Office shall ensure that, with respect to a combination product, a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product. The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.
The Office shall, with respect to the premarket review of a combination product—
ensure that any meeting between the Secretary and the sponsor of such product is attended by each agency center involved in the review, as appropriate;
ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and
ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.
In seeking agency action with respect to a combination product, the sponsor of such product—
shall identify the product as a combination product; and
may request in writing the participation of representatives of the Office in meetings related to such combination product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.
Not later than 4 years after December 13, 2016, and after a public comment period of not less than 60 calendar days, the Secretary shall issue a final guidance that describes—
the structured process for managing pre-submission interactions with sponsors developing combination products;
the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency’s best advice based on the information provided during such pre-submission interactions;
So in original. The word “and” probably should appear.
the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached through a meeting under such paragraph (2);
So in original. The semicolon probably should be a period.
In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law.
Any dispute regarding the timeliness of the premarket review of a combination product may be presented to the Office for resolution, unless the dispute is clearly premature.
During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The Commissioner of Food and Drugs shall consult with the Director of the Office in resolving the substantive dispute.
The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the Secretary shall consult with stakeholders and the directors of the agency centers. After such consultation, the Secretary shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the Secretary from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.
Not later than one year after October 26, 2002 (except with respect to clause (iv), beginning not later than one year after December 13, 2016), and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—
describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions;
identifying the number of premarket reviews of such products that involved a consulting agency center;
describing improvements in the consistency of postmarket regulation of combination products; and
identifying the percentage of combination products for which a dispute resolution, with respect to premarket review, was requested by the combination product’s sponsor.
Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center.
As used in this subsection:
The term “agency center” means a center or alternative organizational component of the Food and Drug Administration.
The term “biological product” has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262
The term “market clearance” includes—
approval of an application under section 355, 357,
See References in Text note below.
360e, or 360j(g) of this title;
a finding of substantial equivalence under this part;
approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262
The terms “premarket review” and “reviews” include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [42 U.S.C. 262
], including with respect to investigational use of the product.
[June 25, 1938, ch. 675, § 503], [52 Stat. 1051]; [Oct. 26, 1951, ch. 578, § 1], [65 Stat. 648]; [Pub. L. 87–781, title I, § 104(e)(2)], Oct. 10, 1962, [76 Stat. 785]; [Pub. L. 91–601, § 6(e)], formerly § 7(e), Dec. 30, 1970, [84 Stat. 1673], renumbered [Pub. L. 97–35, title XII, § 1205(c)], Aug. 13, 1981, [95 Stat. 716]; [Pub. L. 100–293], §§ 4–6, Apr. 22, 1988, [102 Stat. 96–98]; [Pub. L. 100–670, title I, § 105], Nov. 16, 1988, [102 Stat. 3983]; [Pub. L. 101–629, § 16(a)], Nov. 28, 1990, [104 Stat. 4526]; [Pub. L. 102–108, § 2(d)], Aug. 17, 1991, [105 Stat. 550]; [Pub. L. 102–300, § 6(d)], June 16, 1992, [106 Stat. 240]; [Pub. L. 102–353], §§ 2(a)–(c), 4, Aug. 26, 1992, [106 Stat. 941], 942; [Pub. L. 104–250, § 5(a)], Oct. 9, 1996, [110 Stat. 3155]; [Pub. L. 105–115, title I], §§ 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, [111 Stat. 2324], 2327, 2328; [Pub. L. 107–250, title II, § 204], Oct. 26, 2002, [116 Stat. 1611]; [Pub. L. 108–282, title I, § 102(b)(5)(F)], Aug. 2, 2004, [118 Stat. 903]; [Pub. L. 113–54, title II, § 204(a)(1)]–(4), (b), Nov. 27, 2013, [127 Stat. 630–635]; [Pub. L. 114–255, div. A, title III, § 3038(a)], Dec. 13, 2016, [130 Stat. 1105]; [Pub. L. 117–328, div. FF, title III, § 3621], Dec. 29, 2022, [136 Stat. 5877].)