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CDRH Ombudsman’s Office

Melissa SageDeputy Ombudsman

Center for Devices and Radiological HealthFood and Drug Administration

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CDRH Ombudsman’s Office Contact

Abiy Desta, CDRH OmbudsmanMelissa Sage, CDRH Deputy Ombudsman

Main Mailbox: CDRHOmbudsman@fda.hhs.govPhone: (301) 796-5699Confidential fax: (301) 847-8516

Website: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm

___________________________________________________________________________

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Discussion Today:

• What is an Ombudsman?

• CDRH Ombudsmen Roles & Responsibilities

• CDRH Appeals Process & Expectations for Appeal Meetings

www.fda.gov

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What is an Ombudsman? • Term that has evolved to denote someone in any

organization who receives and investigates complaints in an informal, unbiased manner.

• United States Ombudsman Association (USOA) defines a governmental ombudsman as “an independent, impartial public official with authority and responsibility to receive, investigate or informally address complaints about governmental actions, and, when appropriate, make findings and recommendations, and publish reports.”

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• Appointed to receive and investigate complaints about CDRH and to mediate or otherwise resolve disputes in an informal, unbiased manner between the Center and entities doing business with the government– Regulatory

– Scientific

– Administrative Matter

CDRH Ombudsman’s Office

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• Any Interested Party

• Regulated Industry

• Law firms

• Health care practitioners and providers

• Consumers and patients

• Advocacy groups

• Professional societies

• Internal CDRH Staff

Who contacts the Ombudsmen?

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• Receive and investigate complaints

• Respond to inquiries

• Discuss formal and informal dispute resolution options– disputes of a scientific, regulatory, or procedural nature

• Manage CDRH’s Appeal Processes

• Receive feedback about CDRH programs and overall performance

• Report systemic issues and propose solutions

• Advise the Office of the Center Director and make recommendations on ways to ensure that CDRH’s procedures, policies, and decisions are of the highest quality and are fair and equitable

What Do the Ombudsmen Do?

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• Values as described by the following Ombudsman Organizations: COFO, USOA, & IOA

• Confidential – If requested, hold all information confidential unless threat of harm to oneself or others, or case of criminal activity

• Neutral & Impartial – Work to resolve disputes without taking sides

• Informal – Voluntary. Does not make regulatory or scientific decisions. No formal investigations.

• Independent – Free from outside control or influence as much as possible. Not an Agency spokesperson.

Guiding Principles

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• Take sides in a dispute or advocate for a side• Overturn a regulatory decision or action or force

anyone to do so• Work on a dispute that is pending in legal process

or in formal appeals process• Violate guiding principles

• Questions about appeals to the Office of the Commissioner (e.g., RFDs) should be directed to the FDA Ombudsman in the Office of the Commissioner (Laurie Lenkel)

Ombudsman Will Not

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• Informal and efficient

• Unique position – high level but not management

• Deep understanding of Center operations

• Adept at interacting with FDA Staff

• Improve communications and working relationships

• Help to navigate very complex FDA/CDRH

• Unbiased sounding board and advice

Why Use the Ombudsman?

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• Miscommunication or lack of communication❖ I have a device that’s being detained by customs, I’ve been told the matter has been

referred to CDRH but no one will tell me anything else.❖ I have submitted a pre-amendment determination request for a device with CDRH and I

have not heard back from CDRH in four months.

• Request for mediation of dispute between review team and stakeholder❖ Review team is misinterpreting the data we submitted and we appear to have reached a

roadblock.❖ We are being asked to provide performance data that we’ve never been asked to provide in

previous versions of this same device.

• Request for information and advice regarding appeals❖ I have received a “Not Approvable” letter from the CDRH, how do I appeal this decision? ❖ I have received a “Major Deficiency” letter that I strongly disagree with. What are my

options?

When to Contact the Ombudsman

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• No formal submission needed, no fee• Listen, Ask questions (history, desired outcome, etc.), and

Review options for moving forward• Depending on the situation, we may:

– Seek additional information from CDRH Staff– Point you in the direction of applicable laws, regulations, or

policies– Participate in meetings (actively or passively) to support

effective communication – Facilitate or mediate discussions, or use shuttle diplomacy to

share concerns and encourage open communication– Refer you to someone else (SME or elsewhere in Agency)

What to Expect When Contact Ombuds?

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• Guidance Documents

❖CDRH Appeals Processes -- published in final in 2013

❖CDRH Appeals Processes: Questions and Answers About 517A -- published in final in 2014

CDRH Appeals Process

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CDRH Appeals Process• 21 CFR 10.75 Appeals – Key Points

– “Appeal” refers to a request for supervisory review as provided by 21 CFR 10.75

– Organizational hierarchy:• Branch Division Office Center

– Appeals under 10.75 can be carried through the Center to the Commissioner’s Office (further appeal up the supervisory chain if dissatisfied with appeal decision)

– Although most appeals are for pre-market actions, guidance applies to pre-market and non-premarket decisions

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• The supervisory review process was significantly changed in 2012 by FDASIA Section 603, which added Section 517A to the FD&C Act– Section 517A introduced the concept of a “significant

decision”

– Section 517A introduced statutory timeframes and other requirements for appeals of significant decisions

• CDRH intends that the timeframes and procedures specified in Section 517A will apply to each sequential request up the supervisory chain

FDA Safety and Innovation Act (FDASIA)

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• Significant Decisions (517A decisions)– Statutory Timeframes

• Timeliness– Appeal must be received within 30 days of date of decision

– Appeals received after day 30 will be declined as untimely

– No provision in the statute for extensions or waivers, or for partial submissions or placeholders

• Meeting or Teleconference– Meeting scheduled within 30 days of the Center’s receipt

– Decision rendered within 30 days of the meeting

• No Meeting or Teleconference– Decision rendered within 45 days of the Center’s receipt

Section 517A of the FD&C Act

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• Applies only to “Significant Decisions” concerning submissions under the 510(k), PMA, HDE, & IDE Programs

• Types of decisions not defined• FDA Publication of Q&A About 517A Guidance Document –

provide interpretation of the law: – 510(k)

• Not Substantially Equivalent; Substantially Equivalent

– PMA/HDE• Not Approvable; Approvable• Approval; Denial

– IDE• Disapproval; Approval

Section 517A of the FD&C Act

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• Not constitute 517A decisions - Do not trigger statutory requirements of Section 517A of the FD&C Act

• Appeal process still available under 21 CFR 10.75

• Timeliness - Appeals will generally be considered untimely if received after 60 days of the date of the decision

• CDRH intends to conform to the timelines of significant decisions

Decisions Other than 517A Decisions

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• Examples per Q&A Guidance Document:

– 510(k) Requests for Additional Information

– PMA Major Deficiency Letter

– Refuse to Accept Letters (510(k) and PMA)

– Postmarket Surveillance Orders under Section 522 of the FD&C Act

– Warning Letters

– 513(g) Determinations

Decisions Other than 517A Decisions

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• Cover Letter – identify document as a 10.75 appeal request

• Open with statement: Appealing to (Office)(Center) Director, request for supervisory review of decision

• State whether you want to make your case via teleconference or in-person meeting

• Executive summary of situation and basis for appeal / nature of disagreement

• Close with statement of remedies being requested e.g. SE / approval, reopen file for review

• Attachments with supporting documentation

10.75 Appeals – Recommended Format

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• Receipt of appeal package will be acknowledged• If requested, a meeting or telecon will be scheduled

– Regulatory Affairs specialist or Ombudsman rep will contact you to schedule the meeting

– Opportunity to present your case directly to the appeal authority– Review team may be present at the meeting but meeting is run by

the appeal authority; team is there to ask clarifying questions if needed

• There may be follow-up questions from the appeal authority after the meeting

10.75 Appeals – Process

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10.75 Appeals – Meetings• Typical meeting – what you

might expect:– Introductions

– Ground Rules

– Company Presentation

– Appeal Authority Questions

– CDRH attendees are expected not to intervene or challenge company during the meeting, but at appeal authority’s discretion may ask clarifying questions.

– Closure

• Appeal authority usually comes prepared with questions

• Recommendations: – Plan for a 1 hour meeting

– Allot minimum of 10 minutes for questions (either throughout meeting or at end)

– Focus discussions on the topic being disputed

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• By regulation, an appeal must be based on the information in the administrative file as of the date of the decision being appealed

• If new information is presented, it may not be considered as part of the materials for rendering a decision – is at the discretion of the appeal authority

• Further appeal up the supervisory chain if dissatisfied with appeal decision

10.75 Appeals – Considerations

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• Both 517A & Non-517A appeals receive a formal written decision letter

• Decision customarily is one of the following: – Overturn the decision of the Center employee– Uphold the employee decision– Referral of the matter back to the employee for

reconsideration under defined conditions

• Usually includes information on next steps, including possible path forward, as well as further options for appeal

10.75 Appeals – Decisions

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Abiy DestaOmbudsman

Melissa SageDeputy Ombudsman

CDRHOmbudsman@fda.hhs.gov301-796-5699

Confidential fax: 301-847-8516______________________________________

Questions/Comments

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