Demystifying the FDA Appeals Process

Demystifying the FDA Appeals Process
By Yoon Hee Hong and David Lim, PhD, RAC, CQA
For more than a decade, there has been confusion about the appeals process at the US
Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).
There are several avenues to file an appeal, each with specific requirements.
This article aims to clarify the CDRH appeals process so stakeholders can use it
effectively. The relevant processes for FDA’s Center for Drug Evaluation and Research
(CDER) and Center for Biologics Evaluation and Research (CBER) also are described in
this article.
CDRH Appeals Processes
The general practices and procedures for stakeholders in response to FDA’s action are
described in Title 21, Code of Federal Regulations (CFR), Parts 10, 12, and 17. At CDRH,
stakeholders who disagree with an action or decision by the center can request further
review through the available processes.1-2
In December 2011, FDA published Draft Guidance for Industry and Food and Drug
Administration Staff to assist industry professionals in the appeals process. Timelines and
practical tips, such as guidance about the effectiveness of certain types of appeals, are
included.3
However, to use the various available processes to resolve a dispute most effectively,
stakeholders need to evaluate each available process, or any combination thereof, based
on various factors.
Awareness of the Parties’ Position through Discussion, Mediation
At CDRH, disputes commonly arise when parties (the stakeholders and FDA) involved in
the process have different goals. This is due largely to inter alia, differing views on the
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Table 1. Regulatory Processes
During Premarket
yy Premarket notification [510(k)]
yy Premarket Approval (PMA) Application and
Humanitarian Device Exemption (HDE)
yy Pre-IDE
yy Investigational Device Exemption (IDE)
yy Response to a Section 513(g) request for device
classification information
During Postmarket
yy
yy
yy
yy
Warning and untitled Letters
Application Integrity Policy
Requirements for a Postapproval Study (PAS)
Requirements for a 522 Postmarket Surveillance
study, or the conditions under which such a study
would be required
yy Request for additional information from a Medical
Device Report
subject issues and interpretation of relevant and applicable standards, rules, policies,
regulations and requirements.
Thus, it is important for both parties to understand and recognize the issues and
viewpoints so disputes can be resolved in the least burdensome manner, through an
open discussion and better awareness, and as quickly as possible without compromising
patient safety. This can be achieved in the least invasive manner through discussion with
CDRH staff, division management and the CDRH ombudsman.
In this approach, CDRH needs to clarify its views in a practical and reasonable manner and should recommend how issues should be addressed. In response, stakeholders
should consider CDRH’s position carefully and address its concerns in a way that is scientifically sound and reasonable.
Request for Supervisory Review
When a dispute arises during the review process and cannot be resolved by the reviewer
and the stakeholder, a supervisory review could provide the quickest and most efficient
way to resolve a dispute. While trained reviewers have sound views and judgment on
issues, those of supervisors may differ based on various factors (personal viewpoints
and interpretation of the scientific facts, regulatory requirements, existing policy, etc.).
Supervisory review can be requested during many regulatory processes (see Table 1).
Although the pre-investigational device exemption (IDE) process is informal and not
binding on any parties, the subject matter communicated and agreed to (e.g., for an IDE,
510(k) or PMA) likely will be CDRH’s position and expectation during the review.
In addition, since CDRH relies on established standards’ testing requirements, if
stakeholders do not use those standards and fail to provide scientifically sound and reasonable justification, differing views and subsequent disputes can easily develop. Thus,
it is practical and helpful if stakeholders reach agreement with the CDRH branch, division
and office early in the process, through the supervisory review process, if necessary.
Basically, when a stakeholder disagrees with a CDRH decision, the stakeholder must
go through the proper channels, starting with the immediate supervisor of the staff member who rendered the adverse decision. Generally, the appeal moves in the following
order: branch -> division -> office -> center -> commissioner.
For example, if a reviewer in a branch office rendered the adverse decision, the stakeholder should appeal by filing a request for review at the division level. It is important to
follow the proper chain of command to resolve disputes effectively.
In the event the disputes cannot resolved at the center level, the matter can be escalated to the Office of Commissioner through a petition or appeal under 21 CFR Part 10,
which is generally a longer process. The supervisory review request must clearly define
the dispute and should be in the following format:
• cover letter stating the stakeholder’s request concerning a 510(k) or PMA (including
application numbers, if available) for a meeting (in-person, by telephone, video conference, or Advisory Panel meeting) with a clear statement of the issues in dispute and a
discussion of why the request of review should be granted
• executive summary (4–6 pages)
• copies of relevant documents cited in the executive summary as references or
appendices
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Table 2. DRP Process
Steps
Timeline
12 weeks prior
Activities
•
•
10 weeks prior
9 weeks prior
1. Prior to the
meeting
•
Parties must submit an electronic index of materials that will be
included in each Panel Packet. The ombudsman will distribute the
indices to the parties.
•
Parties should raise any objections regarding the indices of materials.
•
Two electronic copies of the complete Panel Packet should be
submitted to the ombudsman for review and comment. The
ombudsman then will share files with both parties. Each party may
raise objections and file them with the ombudsman.
•
•
Parties should submit 20 hard copies and 20 CDs of each final packet.
Each party should submit PDFs of redacted and unredacted panel
briefing materials for forwarding to the Freedom of Information (FOI)
office and the Division of Dockets Management.
Please note that the stakeholder may request that only the redacted
copies be viewed by panel industry representatives.
8 weeks prior
6 weeks prior
•
•
Parties should submit one hard copy and one electronic copy of the
slides. The ombudsman will send the slides to the other party and
finally to the panel members. No changes may be made after the
slides have been sent to the panel members.
•
The stakeholder speaks first, then FDA, followed by other interested
parties, if available.
Panel members may ask questions directly to the parties. However, no
questioning or debate is allowed between the parties.
After deliberation, the chair may call for vote if there is no consensus.
The chair will not cast a vote unless there is a tie.
10 days prior
2. During the
meeting
•
•
Within 15 days
3. After the
meeting
10 days after
5 days after
Ombudsman drafts Summary of Scientific Issues and sends copy to
the parties for comment.
Temporary panel members are selected.
•
The chair will draft a Statement of Finding and a draft
Recommendation.
•
Once the drafts are sent to panel members, members have the
opportunity to provide recommendations and comments.
•
•
The chair will sign the final documents.
The documents will be sent to the center director (or commissioner)
for a final decision.
Please note that no new information may be included in the package other than what is
available in the administrative record at the time of the decision. If the stakeholder wants
to include new information, it must revert to the original level of consideration. Thus, it is
critical to have identified and discussed the potential issues early in the process by initiating a dialogue with CDRH.
There is no statutory requirement on how quickly a request should be filed, but it is
recommended that requests be filed within 60 days of the decision for which review is
sought.
Generally, if a review meeting or teleconference is held, it is convened within four to
six weeks of receipt of the written request. A decision is rendered and communicated to
the stakeholder within six weeks after receipt of the request, or within six weeks after the
review meeting.
The timeline is influenced by various issues (e.g., nature and complexity of the issues
and CDRH resources). A telephone conference is the quickest way to begin the process.
Advisory Panel Meeting Should Be Avoided, Unless Necessary
The stakeholder has the option to request the review authority to refer the matter to an
external Advisory Panel for an expert recommendation. If granted, the Advisory Panel’s recommendation becomes part of the administrative record.
However, due to limited resources and the technical complexity of an expert review,
such a request usually is not considered until the appeal reaches the center level. Since
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panel members primarily are practicing medical professionals at academic institutions and
panel meetings usually are organized by the center, unless the issues involved are novel
and innovative, stakeholders’ real benefits from Advisory Panel meetings are believed to
be marginal.
It is more efficient and effective to use one or more external subject matter experts
(SMEs), special US government employees who can advise the review authority. Such
requests may lengthen the appeals process, and the practical effectiveness of using
SMEs is questionable.
Parallel Review
Parallel review normally occurs when the stakeholder files a new application while supervisory review is pending. Since a new application does not delay other administrative
proceedings that are underway, this approach is duplicative and should be avoided.
Paper Reviews
Intermediate-level decisions made regarding the following issues are handled as “paper
reviews” and are not considered final:
• 510(k) requests for Additional Information (AI letters)
• disputes within a Pre-IDE submission, Warning Letters, and Requests for Additional
Information associated with an adverse event report (Medical Device Reporting (MDR))
Review Meeting or Teleconference
The review authority may call a meeting or teleconference to allow the stakeholder to
present its case directly. One possible outcome may be a negotiation for a mediated
agreement between the parties. Although the stakeholder may elect not to hold the review
meeting and instead submit a written review of the case, working through a teleconference or a meeting is recommended.
The point of contact is the FDA staff member who is managing the review. The stakeholder should submit two written copies of the request to the Document Mail Center (DMC):
US Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – W066-G009
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
An additional copy of the request may be sent to the CDRH ombudsman and a copy
should be included for requests to the Center Director, but this is optional for all other
requests:
CDRH Ombudsman
Center for Devices and Radiological Health
WO66 Room 5428
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Requests made to the center director are managed by the Office of the Ombudsman.
Requests made to the Office of Device Evaluation and the Office of In Vitro Diagnostic
Device Evaluation and Safety (OIVD) about premarket decisions generally are managed by
designated individuals such as regulatory advisors.
The Medical Devices Dispute Resolution Panel
The Medical Devices Dispute Resolution Panel (DRP) serves as an independent review
panel of scientific disputes or controversy between an outside stakeholder and FDA. A
request for a DRP can be made only at the center level or above. The DRP also may be
convened to provide recommendations to the Office of the Commissioner in response to a
request for reconsideration of a PMA approval or a denial.
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Table 3. Types of Hearings
Type
Issue
Formal Evidentiary
Public Hearing
(21 CFR 12)
•
•
Process
Section 515(g) of the FD&C Act on
premarket approval applications and
product development protocols; or
the commissioner concludes it is in
the public interest to hold a formal
evidentiary hearing on any matter
before FDA
Part 12 hearing involving issuance,
amendment or revocation of a regulation
must be submitted on or before the
30th day after the date of publication of
a final regulation or the 30th day after
publication of a notice withdrawing a
proposal initiated by a petition under 21
CFR 10.25(a).
If the hearing request involves the
issuance, amendment or revocation of an
order, the request must be made within
30 days after the issuance of a notice of
opportunity for hearing.
The commissioner will then review all field
requests for hearings
The party with the right to a Part 12
hearing may waive the right to a hearing
and request a hearing under Part 13, 14
or 15.
Part 12 details the procedure on
submission of pleadings, prehearing
conferences, presentation of evidence
and filing of motions.
Two copies of submissions are to be filed
with the Division of Dockets Management.
Public Hearing
Before a Board of
Inquiry
(21 CFR 13)
•
review of medical, scientific and
technical issues
Proceedings are conducted as a scientific
inquiry and not as a legal trial. Rules of
evidence do not apply.
Notice will be published in the Federal
Register and submissions are to be filed
with the Division of Dockets Management.
Public Hearing
Before a Public
Advisory Committee
(21 CFR 14)
•
review of a performance standard for
a radiation-emitting electronic product
by FDA’s Technical Electronic Product
Radiation Safety Standards Committee
(TEPRSSC)
classification of device under Part 860
establishment, amendment or
revocation of a performance standard
review of a PMA or Product
Development Protocol (PDP)
review of the Quality System
Regulation
establishment of minimum national
uniform quality standards for
mammography facilities
FDA will publish a notice in the Federal
Register of Advisory Committee meetings.
Ten copies of written submissions to a
committee are to be sent to the executive
secretary unless stated otherwise in the
Federal Register notice.
The submissions need not be sent to the
Division of Dockets Management.
proposals to allow persons to order
custom devices
proposed Quality Systems Regulation
proposed exemptions from federal
preemption of state and local device
requirements
A public hearing is held at the discretion
of the commissioner.
FDA will publish a notice of the hearing in
the Federal Register.
Scope of the hearing is determined by the
notice of the hearing and any regulation
under which the hearing is held.
Section 520(g)(4) and (g)(5) of the
FD&C Act, relating to disapproval of
an Investigational Device Exemption,
or notice of a proposed withdrawal of
approval
21 CFR 814.46(c), relating to
withdrawal of approval of a PMA
rescission of a 510(k) clearance
an order suspending or revoking
an FDA certificate issued to a US
mammography facility pursuant to the
MQSA
This type of hearing is initiated by a notice
of opportunity for hearing from FDA.
The person offered a hearing has a
specific amount of time to request the
hearing. The request should include
genuine and substantial issues of fact
that warrant a hearing, otherwise such
request may be denied. 21 CFR 16.26(c).
At least one day before the hearing, FDA
and the party, respectively, will provide
written notice of any published articles or
written information to be presented at the
hearing.
The hearing is informal and the rules of
evidence do not apply.
•
•
•
•
•
Public Hearing
Before the FDA
Commissioner
(21 CFR 15)
•
Public Hearing
Before the
Food and Drug
Administration
(21 CFR 16)
•
•
•
•
•
•
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The DRP is convened either by the center director, to provide advice about a scientific controversy or a matter in dispute that has come to the director’s attention, or upon
approval of a stakeholder request for an appeal at the center level.
A stakeholder must have exhausted the supervisory review under 21 CFR 10.75 below
the center level to request a DRP. The request for a DRP may be included in the 10.75
supervisory reviews. In that case, the matter must have been before the Advisory Review
Panel first.
A review request including a request to convene a DRP should be submitted within 30
days of the date of the action that is subject to dispute. However, a request for an extension can be submitted to the ombudsman.
The panel consists of a minimum of five standing members, who serve four-year
terms, and three temporary members. Three of the five standing members, including the
chair, are voting members and come from various scientific backgrounds. The two other
standing members are non-voting members and represent consumer and industry interests. The three temporary members are chosen at the time of the DRP on a case-by-case
basis based on their scientific expertise and the issue under consideration.
Once a DRP review is granted, a three-step process begins (see Table 2).
Petition
Generally, the main purpose for filing a petition is to ask FDA to take or refrain from taking an action, reconsider an action or stay an action. Four different petitions are available,
with the citizen petition and request for administrative reconsiderations the most commonly used.
Citizen Petition
Any interested person can submit a citizen petition to challenge an FDA action or decision,
or to request an action from FDA. When filing a citizen petition, it is crucial to follow specific format requirements laid out in 21 CFR 10.30.
The petition must include the following information:
• citation of the statutory provisions upon which the petition is based (if known)
• complete description of the action requested, including the exact wording of any proposed regulation or order
• statement of the factual and legal grounds for taking the requested action
• information on any environmental impact
• certification that the petition includes the full information and views relied upon
All citizen petitions must be filed with the FDA’s Division of Dockets Management.
Dockets Management
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061, HFA-305
Rockville, MD 20852
Petition for Administrative Reconsideration of Action (21 CFR 10.33)
Any person may file this petition to challenge part or all of a decision rendered by the commissioner. The petitioner must file within 30 days of the decision. Further requirements for
filing this petition are described in 21 CFR 10.33 and 10.20.
The petition must include:
• statement of the decision to be reconsidered
• action FDA should take if the petition is granted
• legal and factual grounds relied upon, including identification of relevant information
and views that the petitioner contends were not previously or adequately considered
when the decision was made
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Table 4. Hypothetical Scenarios for Disputes
Situation(s)
Regulatory
requirements
(e.g.,
biocompatibility)
CDRH/
FDA’s Views
Several tests
are required
(e.g., blood
contacting
devices).
Stakeholders’
Views
Suggested Approaches
Not required
due to no
risk. Even if
required, only
few tests are
required.
• Use FDA guidance document(s), Blue Book
Memorandum #G95-1*, and ISO 10993 to
demonstrate the requirements or equivalent
methods.
• Address how biocompatibility testing requirements
are met and communicate with agency reviewers.
• This is not an arguable issue.
• Resolving the issues via a simple email and/or a
telephone call with the reviewer(s), branch chief
and/or division director is recommended.
• Carefully assess the agency’s recommendations.
• Perform a gap analysis between the agency
reviewers’ suggested methods and the firm’s
methods, including risk analysis.
• If the firm believes there are no additional risks with
the proposed methods, present the firm’s further
analysis to agency reviewers for further discussion
unless the firm agrees to follow the agency’s
suggested methods.
• If the firm’s proposed plan is still rejected by the
reviewer(s), seek discussion with the reviewer’s
supervisor for further input.
Testing methods
Two
methods are
recommended.
Agency’s two
recommended
methods
are unduly
burdensome
and
unreasonable.
Software
verification and/
or validation
testing
requirement
Testing at unit,
integration
and system
level with risk
analysis and
address all
anomalies and
potential risks.
Unit testing
is sufficient
and validation
not required
because there
is a minor risk.
•
•
•
•
•
•
Clinical trials
450 patients
are needed for
a trial.
150 patients
should be
enough.
•
•
•
Clinical studies
for in vitro
diagnostic
devices
Request for
reclassification
or request to
stop the agency
from taking an
action
Analysis of
1,500 patient
specimens
needed
Administrative
action
(Petition).
50 patient
specimens
needed
Petition or
injunction in a
court of law.
•
•
•
•
•
Follow IEC 62304:2006.
Follow FDA guidance document.
Perform risk analysis and address and mitigate all
anomalies/potential risks.
Testing and documentation requirements are
based on potential risks imposed by the device.
Work with the reviewers.
Unless there are special circumstances, FDA
recommends a number of patients based on
various factors (e.g., type and nature of a trial,
end-points, patient populations, and statistical
power, etc.).
Work with the agency’s recommendation.
Consider narrowing/changing the intended use, if
necessary, to improve effectiveness or lesson the
regulatory burden.
Unless there are special circumstances, FDA
recommends a number of patients based on
various factors (e.g., type and nature of a trial,
end-points, patient populations, and statistical
power, etc.).
Work with the agency’s recommendation.
Consider narrowing/changing the intended use, if
necessary, to improve effectiveness or lessen the
regulatory burden.
Communicate with the agency.
Proceed with the petition before seeking a court
injunction.
It may be appropriate to seek legal counsel for this
type of matter.
*: The new blue book memorandum #G95-1 (www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm080735.htm)
The petition will be granted only if all of the following criteria are met:
• The petition demonstrates that relevant information or views in the administrative
record were not previously or adequately considered.
• The position of the petitioner is not frivolous and is sought in good faith.
• The petition demonstrates sound public policy grounds for reconsideration.
• Reconsideration is not outweighed by public health or other public interests.
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Table 5. Submissions
Criteria
Address
CDER issues other than generic drug issues
Formal Dispute Resolution Project Manager (DRPM)
Food and Drug Administration
Center for Drug Evaluation and Research
Mail Code HFD-002
5600 Fishers Lane
Rockville, MD 20857
CDER generic drug issues
Director
Office of Generic Drugs
Food and Drug Administration
Center for Drug Evaluation and Research Mail Code
HFD-600
7500 Standish Place
Rockville, MD 20855
All requests for formal dispute resolution with CBER
Formal Dispute Resolution Project Manager (DRPM)
Food and Drug Administration
Center for Biologics Evaluation and Research
Mail Code HFM-007
1401 Rockville Pike
Rockville, MD 20852
Please note that granting the petition does not mean the commissioner gave a favorable decision on the issue. The petition must be filed with the FDA’s Division of Dockets
Management as described above.
Petitions Under Section 515 of the Federal Food, Drug, and Cosmetic (FD&C) Act
If a PMA is denied, the applicant may file a petition to the commissioner under Section
515(d)(4). Moreover, any interested person may request a petition of a Premarket Approval
order. Such petitions are filed as petitions for administrative reconsideration under 21 CFR
10.33 and need to be filed within 30 days of the day of the receipt of the denial of PMA.
Petition for Administrative Stay of Action
According to 21 CFR 10.35, the commissioner may elect to place in abeyance or extend
the effective date of any action pending or following a decision on the matter. A request
must be filed within 30 days of the action for which the stay is requested; however, the
commissioner may allow a petition after 30 days for good cause.
Please note the submission itself does not affect a stay of any administrative action.
A request for a stay of action must be filed with the Division of Dockets Management.
Request for Reconsideration of Adverse Decisions on Mammography Facility Accreditation/
Certification (21 CFR Part 900, Subpart B)
Facilities offering mammography services must adhere to national quality standards and be
certified by FDA following accreditation by an FDA-approved accreditation body (AB), according to the Mammography Quality Standards Act (MQSA) (42 U.S.C. § 263b). Upon denial of
such accreditation, a facility has the right to appeal the decision directly to the AB.
However, if the appeal’s outcome is unsatisfactory, the appellant facility may request
reconsideration of the adverse decision to the Division of Mammography Quality and
Radiation Programs (DMQRP).
Such a request for reconsideration must be filed within 60 days of the date of the
adverse AB decision. The facilities must include in the request for reconsideration:
• AB’s original denial of accreditation
• all information the facility submitted to the AB
• copy of the AB’s adverse appeal decision
• statement of the bases for the facility’s disagreement with the adverse decisions of AB
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Three copies of a request for reconsideration must be sent to:
US Food and Drug Administration
Center for Devices and Radiological Health
Division of Mammography Quality and Radiation Programs
Attention: Accreditation and Certification Branch
10903 New Hampshire Avenue
WO66-4675
Silver Spring, MD 20993
Within 60 days of receipt of the request, DMQRP issues a decision in writing. If the facility
is still not satisfied with the decision, it has the right to a hearing before the Departmental
Appeals Board.
Generally, hearings are time-consuming and involve several procedural steps (see
Table 3).
Judicial Review
To invoke a judicial review, stakeholders are encouraged to exhaust all administrative remedies with FDA first. In cases where the stakeholder has a pending request for review with
FDA and also has filed for a judicial review, FDA is likely to ask the court to refer the matter back to FDA. Moreover, FDA does not give judicial advice and encourages submitters to
seek their own attorney.
Bias and Suspected Retaliation
If the stakeholder suspects bias or retaliation on the part of center employees as a result
of filing an appeal, the stakeholder should contact the ombudsman immediately and provide the necessary documents establishing bias or retaliation. If the ombudsman decides
that there is merit to the case, the issue will be forwarded to the center via independent
channels.
Our Suggested Approaches
Table 4 contains some of the authors’ suggested approaches under the hypothetical situations. Each situation should be evaluated on a case-by-case basis as the surrounding
circumstances might be significantly different.
CDER and CBER
+CDER and CBER diverge from the CDRH appeals process if the sponsor decides to
file a formal dispute resolution.4 Such dispute resolutions can be filed only after division
level remedies have been exhausted. Also, the sponsor may decide to contact the CDER
or CBER ombudsman to resolve the issue if the formal dispute resolution fails.
Further, 21 CFR 312.48 and 21 CFR 314.301 specifically address the dispute resolution for the Investigational New Drug (IND), the New Drug Application (NDA) and the
Abbreviated New Drug Application (ANDA) processes respectively.
Formal Dispute Resolution
It is important to note that a sponsor also may request an Advisory Committee review
as described in the CDRH appeals process. The sponsor also needs to ensure that no
information is included in the request that is not already in the administrative files. The
submission should include the following items:
• cover sheet that clearly identifies the submission as FORMAL DISPUTE RESOLUTION
REQUEST in bold, uppercase letters
• application number (IND, NDA, BLA, ANDA), if applicable
• proprietary name and established name for a product in CDER; proper name and trade
name for a product in CBER
• division or office where the application is filed
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• proposed indication(s), if applicable
• brief but comprehensive statement of each issue to be resolved (Clearly describe the
issue to be resolved. Identify the issue as scientific, procedural or both.)
• a statement of the steps that have been taken to resolve the issue, including informal
dispute resolution
• identification of possible solutions, including, for scientific issues, whether an Advisory
Committee review is requested
• statement of the expected outcome
• statement identifying the division that issued the original decision on the matter and,
if applicable, the last agency official who attempted to formally resolve the matter
• list of documents previously submitted to the agency that are deemed necessary for
resolution of the issue(s) (If a sponsor prefers, copies of such documents may be
resubmitted to the agency.)
• statement that the previous supervisory level has received and had the opportunity to
review all of the material relied on for dispute resolution
• name, title, email address and telephone and fax numbers of company contact for the
appeal
The DRPM will forward the documents to the respective CBER or CDER official. The official
will provide a written response to the sponsor, either disagreeing or agreeing with all or
part of the desired outcome. If the official disagrees, the written response will provide the
reasoning.
For Prescription Drug User Fee Act (PDUFA) products, the center official must render
a decision within 30 days from the DRPM’s receipt of the request, either by phone or by
written response. If the response is made by phone, the official will send a written confirmation within 14 days of the phone call.
For non-PDUFA products, the official should review the request expeditiously and
respond in a timely fashion.
If the sponsor requests an Advisory Committee review, it is left to the center official’s
discretion whether to convene a meeting. The official must respond within 30 days of such
a request.
If an Advisory Committee makes recommendations, it is crucial to note that the
agency is not bound by the committee’s advice. Such denial of a recommendation is not
subject to judicial review. If an advisory committee review is denied, the sponsor may
appeal the denial via the chain of command, first at the center, and then to the Office of
the Commissioner via the supervisory appeal process.
Conclusion
The appeals process is an avenue for a stakeholder to pursue if it feels an incorrect decision has been rendered and if there are reasonable grounds to believe CDRH’s decision is
unjustified.
As noted in this article, multiple avenues are available to appeal an FDA decision, with
specific deadlines and formats. Each process is associated with a fair amount of time and
effort, thus all factors should be considered before deciding which process to use.
Whichever process is chosen, the stakeholder should carefully assess all of the factual information and data to itself a reasonable awareness of how the agency has been
rendering decisions and whether its information is based on scientifically sound and clinically meaningful data.
Overall, for a CDRH appeal, it is recommended communication (e.g., an informal
phone call) and mediation with the help of the center’s ombudsman be the first route
taken. The most common and effective way to resolve disputes are through the supervisory review under 21 CFR 10.75.
While the supervisory review process is strongly recommended, a stakeholder may file
a petition or request a hearing in specific situations, as discussed previously.
Judicial review should be the last resort. But if the judicial review process is used,
seeking help from regulatory counsel may be appropriate.
The CBER and CDER appeals processes mirror some of the CDRH appeals processes,
but distinguish themselves in case of an appeal above the division level.
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Despite a constantly evolving regulatory environment, the FDA appeals processes
are heavily anchored in FDA regulations and the FD&C Act and, thus, will remain mostly
unchanged. It is reasonable to speculate, however, that the Medical Device User Fee Act
(MDUFA III), which take effect 1 October 2012, could potentially influence the appeal process, as the agency’s resources likely would be diverted to facilitate the review process.
References
1. Medical Device Appeals and Complaints—Guidance for Dispute Resolution, February 1998.
2. Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute
Resolution Panel; Final Guidance for Industry and FDA, July 2001.
3. Draft Guidance for Industry and Food and Drug Administration Staff—CDRH Appeals Processes, 27 December 2011.
4. Guidance for Industry—Formal Dispute Resolution: Appeals Above The Division Level, February 2000.
Legal Disclaimer
The information contained in the article is for general guidance on matters of interest only and does not amount to legal advice.
Application of laws and the appeal process can vary drastically based on individual facts involved. Before making any decision,
you should consult an attorney.
Authors
Yoon Hee Hong is an attorney and works at Regulatory Doctor (www.RegulatoryDoctor.com) on various regulatory issues including FDA appeals, labeling and biosimilars. She can be reached at [email protected]. David Lim, founder of Regulatory
Doctor, holds a PhD in biological sciences, is a certified quality auditor (CQA) by the American Society for Quality and has earned
the RAC. Lim provides webinars and career-training programs at www.GlobalComplianceSeminar.com as a seminar leader, regulatory coach, mentor and consultant. Dr. Lim serves as a member of the Advisory Board at www.NanoIVD.com and can be reached
at [email protected].
© 2012 by the Regulatory Affairs Professionals Society. All rights reserved.
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