On the FDA Voice Blog, David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell, from the FDA’s Center for Devices and Radiological Health, Office of the Ombudsman, discussed disputes with agency stakeholders and the definition of a “significant decision” in these disputes.
They write: “Disputes can occur at any stage of a particular interaction, from an initial inquiry or pre-submission review to a final regulatory decision on an application or submission.”
“When discussion and interaction through the Division level fails to resolve a dispute, stakeholders usually have several options. By far the most common approach is to request internal agency supervisory review as provided in the Code of Federal Regulations, at 21 CFR 10.75. When a request is made for internal agency review of a decision of an FDA employee, the decision is subject to review by the FDA employee’s supervisor. Generally, such a request for internal agency review is filed with the manager at the next organizational level above the level that either signed the document in dispute or was substantively involved in the decision.”
Important to stakeholders is the agency’s updated guidance document:
“Legislation passed last year by Congress introduced the term “significant decision” to our regulatory lexicon and included certain expectations of how we are to deal with disagreements over such decisions. FDA has proposed its interpretation of what constitutes a “significant decision” in a question and answer draft guidance document, entitled, “Center for Devices and Radiological Health Appeals Processes: Questions and Answers about 517A.” This draft guidance is available for public comment.”
DRAFT GUIDANCE
According to the FDA’s guidance, the agency has: “added the clear timeframes for the processing of appeals of significant decisions in section 517A(b)(2) and (3) to the final version of Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and Food and Drug Administration Staff (2013) (Appeals Guidance).”
SECTION 517A(b)(2) and (3)
Section 517A of the FD&C Act contains provisions for the documentation and review of certain decisions in the premarket review of device submissions. Specifically, 517A(b)(2) and (3) state that:
(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECISIONS.—
(1) IN GENERAL.—The Secretary shall provide a substantive summary of the scientific and regulatory rationale
for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.
(2) PROVISION OF DOCUMENTATION.—Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application.
(b) REVIEW OF SIGNIFICANT DECISIONS.—
(1) REQUEST FOR SUPERVISORY REVIEW OF SIGNIFICANT DECISION.—Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the individual who made the significant decision.
(2) SUBMISSION OF REQUEST.—A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.
(3) TIMEFRAME.—
(A) IN GENERAL.—Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference.
(B) EXCEPTION.—Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.
QUESTIONS ABOUT “SIGNIFICANT DECISION” FROM FDA’S GUIDANCE
FDA: “The documentation and review procedures required by section 517A apply only to “significant decisions” concerning submissions under sections 510(k) (Premarket Notification), 515 (Premarket Approval or “PMA”/Humanitarian Device Exemption or “HDE”) or 520(g) (Investigational Device Exemption or “IDE”).
However, the agency notes, “[s]ignificant decision” is not defined.
CDRH believes the term “significant decision” should include the following:
- 510(k): Not Substantially Equivalent; Substantially Equivalent
- PMA/HDE: Not Approvable; Approvable with Conditions; Approval
- IDE: Disapproval; Approval
- Failure to reach agreement on a protocol under section 520(g)(7)
Alternatively, “CDRH does not believe that actions earlier in the review process constitute ‘significant decisions.’ Thus, refusals to accept/file, requests for additional information, and deficiency letters during the review of a premarket submission would not trigger the requirements under section 517A.”
“SUBSTANTIVE SUMMARY”
Section 517A of the FD&C Act requires the Center to provide, upon request of a person who is seeking to submit or who has submitted a 510(k), PMA, IDE, or HDE, a “substantive summary” of the scientific and regulatory rationale for any significant decision regarding such submission, including documentation of significant controversies or differences of opinion and the resolution thereof.
For decisions that are subject to this provision, the substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following elements:
- An explanation of the rationale for the regulatory decision;
- Documentation of significant controversies or differences of opinion, i.e., ones the resolution of which had a direct bearing on the regulatory decision; and,
- References to published literature and consensus standards upon which the decision-maker relied.
REQUESTING DOCUMENTATION OF “SIGNIFICANT DECISIONS” AND THE FREEDOM OF INFORMATION ACT (FOIA)
FDA interprets section 517A(a)(2) to: “permit persons who have submitted or who are seeking to submit 510(k)s, PMAs, IDEs, or HDEs to request substantive summaries of significant decisions regarding their own device (not the devices of others) without having to file a request under the FOIA.”
“Since FDA will only be providing these summaries to the owner of any proprietary information contained therein, generally there should not be any need to withhold trade secret or confidential commercial information (CCI) or any other information in the summary. If someone other than the owner of a device (generally the device sponsor or manufacturer) wishes to obtain a substantive summary of a significant decision regarding such device, that person would need to file a FOIA request. Generally, trade secret and CCI would have to be withheld in FDA’s response to such a FOIA request but there would be no information exempt from disclosure under 5 U.S.C. § 552(b)(5).”