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

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 o f 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 & Information received by a firm, re-packager Removal Reports or distributor • FDA Inspections Competitors – - Directed – - Routine Internal Device Reviews • Consumer Complaints MedSun Reports • Adverse Event Reports MRAs and other Country – Med Watch Reports Agreements – MDRs (Medical Device Radiation Product Reports Reports), OSB 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 of 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