Medical Device Recalls and Part 806 The Importance of Getting It - - PowerPoint PPT Presentation

Medical Device Recalls and Part 806

The Importance of Getting It Right

Medmarc Insurance September 28, 2016

Steven Niedelman

Lead Quality System & Compliance Consultant King & Spalding LLP 1700 Pennsylvania Ave., NW Washington, DC 20006 +1-202-626-2942 sniedelman@kslaw.com

Niedelman; September 2016

General Recall Authority

• 21 CFR Part 7 - Guidance on Policy, Procedures and

Industry responsibilities (21 CFR 7.40-7.59)

– Defines what is/what is not a recall – Defines classifications of recalls (Class I, II or III) – Instructions on how to conduct a recall – Guidance for firms (voluntary) – Identifies FDA responsibilities – Applies to all products FDA regulates

Does not have the effect of law or regulation – represents agency thinking on the matter

Niedelman; September 2016

Unique Device Recall Authorities

• 21 CFR Part 806 (Medical Device Reports of

Removals and Corrections)

– Prompted by Congressional hearings – Reporting requirement for medical device manufacturers and importers to FDA within 10 business days of decision

• For situations that reduce a risk to health (class 1 & 2

recalls)

• 21 CFR Part 810 (Mandatory Medical Device Recalls)
• Rarely used since enactment in 1990
• Class I situations when voluntary action not taken

– Provides opportunity for due process – FDA may “order” a firm to recall product

Niedelman; September 2016

Related Regulations Involving Recalls

• 21 CFR Part 820 (Quality System Regulation)
• Design control
• Product and process changes
• Validation of device and process changes
• Acceptance activities
• CAPA
• Complaint files and investigation
• Service activities
• 21 CFR 803 Medical Device Reporting
• 21 CFR 807.81(a)(3) Pre-Market Notification

Significant changes are introduced

• 21 CFR 814.39 PMA supplements
• 21 CFR 821.20 Tracked devices

Niedelman; September 2016

What is a Recall?

• Firm’s removal or correction of a marketed product

in violation of the Federal Food, Drug & Cosmetic Act and against which FDA would initiate legal action unless…

– Voluntary action is undertaken by a firm when it determines a device is misbranded under §502 or adulterated under §501 of the Act

• Effective method to remove or correct consumer

products in the market place

• More efficient and less costly alternative to FDA-

initiated court action for removing violative products from the market (seizure) or import detention

Niedelman; September 2016

Corrections and Removals

• Removal means the physical removal of a device from

its point of use for repair, adjustment, relabeling, destruction or inspection. (21 CFR 806.2(i))

• Correction means the report, modification,

adjustment, relabeling, destruction, or inspection of a device without its physical removal. (21CFR 7.3(h))

Niedelman; September 2016

Classes of Recalls

Class I - Situation in which there is a reasonable probability that

the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

‒ “Reasonable Probability” means “that it is more likely

than not that an event will occur”

Class II - Situation in which use of, or exposure to, a violative

product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III - Situation in which use of, or exposure to, a violative

product is not likely to cause adverse health consequences.

Niedelman; September 2016

What Is Not a Recall

• Corrections and Removals, Part 806 is not required for:
• “Market Withdrawal”

– A firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. (21 CFR 7.3(j))

• “Stock Recovery”

– A firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm, and no portion of the lot has been released for sale or use. (21 CFR 7.3(k))

• May include product at logistics and order fulfillment providers

Niedelman; September 2016

Hypotheticals: Recall Definition

• Has a recall occurred?

A sales rep receives the same complaint from two customers that the tip of the SuperSleek cannulae device fractured before surgery. He retrieves all SuperSleek cannulae that the customers have in stock and replaces them to address the complaints.

Niedelman; September 2016

Hypothetical: Recall Definitions

Has a recall occurred?

– VascFast realizes that it printed some inaccurate

information regarding the manufacturing date and location on the packaging for several lots of SuperSleek cannulae and it sends a corrective letter and label to users.

Removal or Correction? Correction!

Niedelman; September 2016

Hypotheticals: Recall Definition

Has a recall occurred?

The misprinted packaging is identified while the affected devices are still in VascFast’s warehouse. The manufacturer repackages all affected devices.

Recall or Stock Recovery? Stock recovery!

Niedelman; September 2016

How Firms Become Aware of Recalls

Carefully monitor all data sources/feeders to determine shifts in trends and “spikes”

• Complaints
• Service reports
• - Parts usage

– Peer review literature – Increase in NCRs – Manufacturing issues – Environmental issues – New product evaluations – Packaging complaints – New information….

Niedelman; September 2016

CDRH May Become Aware of Recalls

• 806 - Correction &

Removal Reports

• FDA Inspections

– - Directed – - Routine

• Consumer Complaints
• Adverse Event Reports

– Med Watch Reports – MDRs (Medical Device Reports), OSB Information received by a firm, re-packager

• r distributor

Competitors Internal Device Reviews MedSun Reports MRAs and other Country Agreements Radiation Product Reports

Not all-inclusive!

Niedelman; September 2016

Data Sources - Recalls:

• There is no “magic number” that may trigger the need

for recall.

– A single catastrophic event may be enough! – Potential severity of risk is important

• Resist rationalizing extent of use to minimize rate of

events.

– Devices are expected to work correctly for their anticipated life. – Manufacturers should establish end of life for devices. – Expired warranties are not an excuse to not do the right thing! – Don’t depend upon physicians expertise to know what to do when the device fails – not everyone is an expert!

• Use an established algorithm for triggering action and

evaluation – do not wait until till it is too late!

Niedelman; September 2016

Triggering Events

• 21 CFR 806.10(a)

– Each device manufacturer or importer shall submit a written report to your FDA district office of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

1. To reduce a risk to health posed by the device; or 2. To remedy a violation of the act caused by the device which may present a risk to health

• 21 CFR 806.10(b)

– The manufacturer or importer shall submit any required report within 10-working (business) days of initiating such correction or removal.

• That is 10 days from the decision to take action!

Niedelman; September 2016

21 CFR Part 7.42: A Firm’s Recall Strategy

• The recall strategy will include the following

elements:

– Depth – level in the distribution chain (i.e., consumers) – Public Warning – purpose is to alert the public that the product being recalled presents a serious hazard to health – Effectiveness Checks – verifies that all consignees at the recall depth specified have received notification and have taken appropriate action

• The recall strategy will specify the method(s) to be

used to conduct the recall and the level of effectiveness checks that will be conducted.

Niedelman; September 2016

Recall Strategy for Voluntary Recall

Established Recall Procedures should include…

• Recall Team:

– Names of persons who will have substantial involvement in recall.

• Recall Coordinator:

– Person with chief responsibility for recall.

• Product Involved:

– Product name, ID number, lot numbers. – Volume of product affected: total boxes and number of units in each box. – Earliest and most recent shipment dates.

• Problem Status:

– Description of problem that created need for the recall.

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Assessment of Hazards:

– Results of Health Hazard Evaluation

• Describe the likelihood of an injury occurring as a result of

the problem and the seriousness of the injury likely to occur

• Consider benefit risk of removing implants
• Consider “medical necessity” situations

– Ease of Identifying Product

• Describe whether customers will be able to identify this lot
• f product easily.

– Degree to Which the Deficiency is Obvious

• Describe whether customers will know there is a defect in

the product or whether product can be used without the customer noticing the defect.

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Assessment of Hazards (cont’d):

– Degree to Which Product Remains Unused

• This should be an estimate based on the amount of product

involved, the last shipment date, and the usage pattern (e.g., single use).

– Continued Availability of the Product

• State whether current production is affected and whether

shipment was stopped as a result of the problem.

• Is containment effective?
• Affected product on hold? In quarantine?
• Will a shortage situation be created?
• Is the product medically necessary?
• Need for repair parts and service replacements

16

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Investigation and Corrective Action:

– Describe the investigation into the cause of the problem. – What the cause was determined to be. – What corrective action was taken.

• Identify root cause!
• Product Reconciliation:

– Compare the amount of product released for distribution with the amount of product shipped. – Discrepancies should be investigated and explained.

• Identification of Customers:

– State whether all customers who received the product have been identified.

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Product Action Strategy:

– Depth of Product Action

• State whether the recall will be to the user level or

distributor level

– Will sub-recalls be needed?

– Conduct of Product Action

• Describe the planned actions. Indicate whether this will be

a field correction or will the product be removed from the field and repaired, reconditioned or destroyed.

– Public Announcement

• State whether a public announcement is necessary and,

if so, the form it will take.

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Communications:

– Type of Notification

• For each type of customer, describe the types of notifications

to be used; e.g., certified mail, telegram, telephone, etc.

• Should communication to the user be through physicians who

can best explain?

• Will patient monitoring be needed?

– Content of Communications

• For each type of communication, describe its contents.

Niedelman; September 2016

Recall Communication

• Must state that the product is subject to recall and why.
• Further use of the product should stop immediately.

– - May require patient monitoring or physician visit

• Instructions on what to do with the recall product.
• Identify the product, size, lot number, serial number, etc.
• Explain reason for recall and hazard involved.
• Should not contain irrelevant qualifications or promotional

materials.

• Should be reviewed by independent set of eyes.
• Follow FDA Model in Regulatory Procedures Manual (RPM).
• Ref: www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm

Niedelman; September 2016

Press Release

• Generally within discretion of recalling company, except

Class I situations.

– Firms are expected to issue a press release in those situations.

• Should obtain FDA concurrence
• Should not be promotional
• FDA may issue its own press release for Class I recalls.
• Companies often issue press for Class II recalls.
• Don’t forget to include copies of press releases on firm

website.

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Disposition of Returned Product:

– Returned product should be either reconditioned or destroyed.

• If reconditioned, suggest discussing plan with FDA

– Assure violation is addressed in reconditioning – Process followed should be documented. – Be sure to maintain full accountability of product shipped

• vs. returned.
• Do not expect 100% accountability
• Make at least three good faith efforts to notify consignees

and retrieve product (letters, visits, calls, etc.) – Be sure to document all activities taken!

Niedelman; September 2016

Voluntary Recall Strategy (cont’d)

• Effectiveness Checks and Closure of the Recall Action:

– Describe when the recall will be considered completed.

• When most or all accounts have responded as to

product on hand.

• - Maintain copies of letters and other written notifications.
• - Maintain response cards used for effectiveness checks.
• Document and quarantine returned product.
• Include those awaiting correction
• Determine when most or all product has either been

reconditioned or destroyed – notify FDA District Office – Offer FDA opportunity to witness destruction » In developing destruction plans, be mindful of environmental issues, EPA, OSHA, etc.

Niedelman; September 2016

Health Hazard Assessments

• Health Hazard Evaluation (HHE) or Health Risk Assessment

(HRA) should be conducted to evaluate risk before any:

– Stock recoveries – Safety alerts – Market withdrawals – Recalls

• HHEs/HRAs should be based on objective evidence of the

device, its intended use and risk created by the situation.

– Should be evaluated by clinical staff who have expertise to effectively evaluate situation and assess risk. – Firms should have established procedures requiring appropriate sign-off within their organization.

• At end of day, in case of indecision, one person must be identified

as accountable.

Niedelman; September 2016

Purpose of HHE and HRA

• Both are assessments of “Risk to Health,” follow the

same process, and use the same documentation.

– HHE is a tool for classifying a voluntary recall by a firm. The evaluation guides FDA in determining the risk to the public from the defective product and appropriate actions for the firm and the FDA to take to protect public health. – HRA is a tool for predicting possible harm that can come from a defective or malfunctioning device. The assessment helps the FDA and the firm determine if any actions are necessary such as recalling the devices or notifying the public about the risk.

Niedelman; September 2016

Data Sources: Health Hazard Assessments

• Determine if issue was included in FMEAS:

– What was severity? – Are known complaints consistent with what was evaluated in FMEA? (i.e., catastrophic outcome for a low or medium severity determination) Have unanticipated issues/complaints arisen? Is re- evaluation necessary?

Thorough, timely investigations are needed to determine how device was used and obtain any incidental information associated with use (e.g., capital equipment may require different investigation than single use product to take other factors into account)

Niedelman; September 2016

Health Hazard Evaluation (HHE)

• CDRH will perform its own Health Hazard Evaluation

(HHE), or utilize established precedents HHEs for similar problems/devices.

• This risk assessment will guide the Center in classifying the

recall into one of the three classes and determine what actions are needed by the firm and FDA to protect the public health.

• Firms should be familiar with how FDA has classified

similar situations in the past as a basis for what actions are expected to be undertaken.

• Search FDA’s Recall Enterprise System (RES) and/or TPLC

medical device data on www.fda.gov

Niedelman; September 2016

Defining the Risk

• Technical assessment of the defect defines likelihood of

device failure.

• Clinical understanding of product defect and real life

situations clarifies risk.

• Evaluation is made by FDA assuming no corrective action

has been taken by the firm.

• Lack of reported injuries does not mean lower risk or

recall classification.

– Be proactive – do not wait for injuries and/or deaths to act!

Niedelman; September 2016

Challenges in Class I Recalls

• Issues where manufacturers and FDA can disconnect:

– Defect is “easily recognizable” by the physician or Health Care Provider (HCP)

• “Work-arounds” are proposed and/or being done

successfully by surgeons or other HCPs – Such activities may distract physician attention from serious issues

– Other systems provide “backup” – “Inconvenience” vs. risk of prolonging/rescheduling an interventional or diagnostic procedure – “Misuse” by healthcare providers

• “Experts have no problem”
• Lack of expertise vs. design or labeling (instructions for

use)

Niedelman; September 2016

“Silent” Recalls:

Common Fact Patterns

• Combining a product “upgrade” with a correction/removal.
• Distributing a “market bulletin.”

– Inform customers of recent device problems and advise of techniques to be used to help prevent those problems.

• Deploying sales representatives to inspect devices in the field to

determine whether a known systemic problem is present.

• Exchanging defective devices for those customers who complain,

without systematically removing the potentially defective devices from the field.

– “Fix on fail”

• Replacing known problematic parts during routine service.

Niedelman; September 2016

Back Door Recalls:

Sample Warning Letters

• Warning Letter to Penumbra, December 2009:

– “[Y]our firm failed to submit its Report of Correction and Removal within the required ten day time frame as required by 21 CFR 806.10(b). Specifically, during our review of records related to distribution of complaints and medical device reports for your [device], it was revealed that from November 2008 you were aware of issues associated with the subject device. As a result, you decided to conduct an exchange action.”

• Warning Letter to Medrad Inc., May 15, 2011:

– Medrad instituted corrective actions that should have been reported as recalls:

• Issued “safety reminder” to health care practitioners

– Upgraded software – Released a disposable kit work-around

Niedelman; September 2016

Service Activities Impact on Recalls

• Service is part of the quality system and not a separate

business unit, therefore service records are quality records!

• Service may be a principal feeder of complaints and

identifier of potential recall situations.

• Service activities should be closely trended based on

complaints, parts usage, routine service and end of life.

• Service provides many opportunities for “silent recalls”

to take place.

– Needs to be carefully monitored by the quality

• rganization.

Niedelman; September 2016

Service Activities Impact on Recalls (con’t)

• Activities that may be “recalls”

– Specifically swapping out defective parts during next preventive maintenance service – Making corrections and taking corrective actions during service visits – Field service reps providing and installing parts on their

• wn

– “Fix on Fail” situations

• Activities that may not be “recalls”

– Repairing or replacing known service parts during routine maintenance

• Includes parts that are identified for routine “checking”

(e.g., belts, hoses, tensioners, etc.)

Niedelman; September 2016

Hypotheticals: Recalls

• The manufacturer of a device incorporates a bulb in its “on-off”

switch that has an expected life of two years. In their preventive maintenance schedule, these bulbs are replaced every two years. Isolated reports of bulbs have been failing at 22 and 23 months.

Recall or Not? Not!

Steady reports have been coming in about failures at 8-9 months

Recall or Not? Recall!

Niedelman; September 2016

Hypotheticals: Recalls

• Service has been receiving an increased number of complaints

about back-up battery depletion. Upon return of the devices for service, the “battery gauge” indicates the battery is fully

• charged. Since this is the back up system, and there have not

been any complaints, those batteries that are reported depleted are removed, recharged and reinstalled.

Recall or Not? Recall!

Niedelman; September 2016

Reporting of Corrections & Removals

Niedelman; September 2016

Scope

General Scope:

21 CFR Part 806 contains regulations governing the reporting of corrections and removals. Manufacturers and importers must “promptly” report corrections to devices and removals of devices when the action is taken to eliminate possible “risk to health.”

• Filing Window - Written reports must be submitted within 10 working

days from the time the correction or removal action is “initiated.”

• “Initiated” means the date of decision to act.

–Amendments to Initial Reports:

• Where corrective action is extended to additional lots or batches of

devices subject to the original action, an amendment to the initial report must be submitted to FDA within 10 working days of initiating the extended action.

Many FDA Districts require filling out their own form… which goes beyond 21 Part 806!

Niedelman; September 2016

History

• Added authority under the Safe Medical Device Act of 1990,

along with Mandatory Recall authority. – First time the word “recall” appeared in the Food, Drug and Cosmetic Act! – Congress saw need to require reporting of recall actions since medical device industry was not complying with recall guidance contained in 21CFR Part 7, and were not reporting recalls to FDA.

• Failure to report a recall that reduces a risk to health

misbrands your device and subjects it to action.

Niedelman; September 2016

Risk to Health

• Part 806 applies to the correction and removal of devices that

pose or may pose a “risk to health.” – “Risk to health” tracks the definitions for Class I and Class II recalls under the voluntary recall regulations. FDA defines the term to mean:

• Reasonable probability that the product will cause serious

adverse health consequences or death, or that,

• The product may cause temporary or medically reversible

adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote. – FDA equates “serious adverse health consequences” with “serious injury.” See 21 CFR § 803.3(a)(1) [MDR definition].

Niedelman; September 2016

Other Requirements

• 21 CFR Part 806 does not apply to correction or removal actions

when a similar report is mandated under Parts 803, or 1004, however, most firms voluntarily file Part 806 reports with the District.

• Part 806 provides that the manufacturer, importer, or distributor

must maintain an internal record of the correction or removal action even when a written report to FDA is not required.

– Internal record must be maintained for a period of two years beyond the expected life of the device. – Record should include all communications regarding the correction

• r removal.

– These will likely be reviewed by FDA during inspections!

Document! Document! Document!

Niedelman; September 2016

Hypotheticals:

Reporting Corrections and Removals

• Which of the following scenarios involve a recall that should be

reported to FDA?

1. Scenario #1: VascFast replaces customers’ stocked SuperSleek cannulae with a new model that handles easier and also resolves a problem that made the cannula prone to breaking inside the aorta. 2. Scenario #2: Testing reveals a dangerous defect in one lot of the SuperSleek that has not yet reached customers but has been sent to distribution centers. The manufacturer replaces all the stock at the distribution centers

Scenario # 1: Yes Scenario # 2; Possibly Yes - depending on the ownership of the product at the distribution centers. If it is no longer under the ownership and control of VascFast, it is reportable!

Niedelman; September 2016

Final Enhancement vs. Recall Guidance

Published October 15, 2014

• Guidance is intended to clarify:
• When a change to a device constitutes a recall
• The difference between a device enhancement and a recall
• Whether the change needs to be reported to FDA under Part

806 Guidance focuses on core issues of distinguishing enhancements from recalls Recalls are conducted for changes to violative devices Enhancements are conducted for changes to non-violative devices Guidance is written in Q & A format with illustrative examples of scenarios that FDA considers to be a recall or enhancement The final guidance does not address when a change to a device requires a premarket submission

Niedelman; September 2016

Final “Enhancement vs. Recall” Guidance

Differentiating between violative from non-violative devices:

Changes intended to resolve a failure to meet specifications or failure

• f the device to perform as represented would constitute a recall.

Such devices are adulterated because they are of a lesser quality than they purport or are represented to possess. Changes to correct labeling that is false or misleading, fails to provide adequate directions for use or otherwise violates labeling requirements would generally be a recall. Labeling changes to non-violative devices (including additional warnings) would not be considered a recall.

Niedelman; September 2016

FDA Draft Guidance: Factors to Consider Regarding Benefit –Risk in Medical Devices

June 16, 2016

• Clarifies how CDRH considers the benefit and risk of

medical devices in these contexts: – Product scarcity if a product would be removed from the market in a recall or enforcement action – Compliance and enforcement (e.g., appropriate regulatory response mechanism following an inspection that was non-compliant with QSR) – Consideration of benefit-risk tradeoffs from patient perspective

• In a company’s HHE, it opens opportunities to

identify benefits of product at time of premarket approval/clearance in the product description

Niedelman; September 2016

Draft Guidance – Benefit and Risk

• What the draft guidance does and doesn’t do:

– Does not change the regulatory classification of recalls or legal definitions of serious injury – Does not change FDA’s HHE strategy for categorizing the seriousness of harm to patients – Does not resolve the issue of qualitative assessment vs. numerical probability calculation

• f likelihood of harm

– It does increase emphasis on duration of patient exposure to harm – It does increase emphasis on estimation of harm upon patient exposure to a “noncompliant manufacturer” not just a “nonconforming device”

Niedelman; September 2016

Summary

• There has been an increased focus on the importance of recalls

throughout FDA.

• The number of recalls has seen a slight dip the past two years.
• Recalls are an effective and efficient way to manage a violative

situation affecting adulterated or misbranded product in distribution.

• It is important that you know the requirements for device recalls

and be timely in your reporting.

• It is important you are able to distinguish between a recall from an

enhancement and be able to defend your position

• Remember, always act in the interest of public health –

it may reduce your risk and liability over time.

Niedelman; September 2016

CDRH Recalls by Classification

by Fiscal year

200 400 600 800 1000 1200 1400 Class 1 Class 2 Class 3

Niedelman; September 2016

THANK YOU

Questions?

Steven Niedelman

Lead Quality System & Compliance Consultant King & Spalding LLP 1700 Pennsylvania Ave., NW Washington, DC 20006 +1-202-626-2942 sniedelman@kslaw.com