Big Legislative Changes: What You Need to Know to Meet the New - PowerPoint PPT Presentation

Big Legislative Changes: What You Need to Know to Meet the New Challenges May 29, 2018 PRESENTED BY: Steven Niedelman Lead Quality System and Compliance Consultant FDA & Life Sciences Practice Group King & Spalding LLP (202) 626-2942 sniedelman@kslaw.com

Today’s Agenda • Impact of FDA Reauthorization Act (FDARA) on medical device industry • aka MDUFA IV • Current status of 21 st Century Cures Act (21CC) implementation of medical device requirements

FDA Reauthorization Act of 2017 FDARA • Effective August 18, 2017 • Contains user fee reauthorizations • PDUFA • MDUFA • GDUFA • BsUFA • Also contains provisions regarding drug development and access, generic drug access 2

MDUFA IV

MDUFA IV (FDARA §§ 201-210) • Significant fee increases, to meet increasing statutory revenue amounts: • FY 2017 actual to FY 2018 actual – Establishment registration: 37% increase – PMAs and PMA supplements: 33% increase – 510(k): 125% increase • New user fee for de novo submissions • 30% of the PMA base fee • Small businesses get a break on 510(k) fee increases • Increase of 12.6% from FY 2017 to FY 2018 • But increase of 33% on PMA-related user fees • No reduction of establishment registration fees • New statutory requirement to apply an inflation adjustment to the user fee every year, including FY 2018 5

User Fees, FY2018-2022 MDUFA III MDUFA IV (FDARA) Fee Type FY 2017 FY 2019 FY 2020 FY 2021 FY 2018 FY 2022 Establishment registration $3,382 $4,624 † $4,548* $4,760* $4,975* $4,978* PMA/BLA $234,495 $310,764 † $300,000* $310,000* $328,000* $329,000* 510(k) $4,690 $10,566 † 3.4% 3.4% 3.4% 3.4% De Novo classification n/a $310,764 † 30% 30% 30% 30% Panel-track supplement $175,871 $233,073 † 75% 75% 75% 75% 180-day supplement $35,174 $46,615 † 15% 15% 15% 15% Real-time supplement $16,415 $21,753 † 7% 7% 7% 7% BLA efficacy supplement $234,495 $310,764 † 100% 100% 100% 100% PMA annualreport $8,207 $10,877 † 3.5% 3.5% 3.5% 3.5% 30-day notice $3,752 $4,972 † 1.6% 1.6% 1.6% 1.6% † Adjusted for inflation * Subject to adjustments for inflation and to meet statutory revenue goals Note: Small business fees are 25% of the listed amounts, except for the 30-day notice (50%) and establishment registration (no reduction) fees 6

Device Provisions in FDARA

Inspections: Risk-Based Schedule (FDARA § 701) • Requires FDA to conduct establishment inspections on a risk-based schedule, using the following factors: • Compliance history • History of recalls • Inherent risk of the device • Inspection frequency and history – Whether there were any FDA inspections in theprevious 4 years – Foreign government inspections – Participation in international device audit programs (e.g., MDSAP) • Replaces statutory requirement to inspect Class II and III device establishments every 2 years 8

Inspections: Uniform Processes and Standards (FDARA § 702) • Requires FDA to establish “uniform processes and standards” for routine (not for cause) device inspections, to include: • Exceptions to processes and standards • Pre-announcement of routine inspections – Within a “reasonable time” in advance – Notification regarding the type and nature of the inspection • Estimate of the inspection timeframe • Opportunity for advance communication regarding working hours and records to be requested • Regular communication during the inspection regarding the inspection status • Draft guidance required by February 18, 2019 9

Inspections: Feedback (FDARA § 702) • New statutory requirement for FDA to provide feedback on afirm’s 483 corrective actions, upon request • Feedback required if: • Request is “timely” • Corrective actions relate to: – Public health priority – Systemic or major actions, or – Emerging safety issue • Response within 45 days after receipt of a request • Feedback is nonbinding 10

Inspections: Draft Guidance (FDARA § 702) • Draft guidance required by February 18, 2019 – Device inspection processes and standards for routine inspections – Feedback on corrective actions – Standard methods for communication regarding inspections and feedback – Standard timeframes for foreign and domestic device inspections • Occurring over consecutive days • Extensions upon investigator’s identification of a reason to the establishment – Practices “to facilitate the continuity of inspections” 11

Inspections: Refusals (FDARA § 702) • Devices are now deemed adulterated if an establishment delays, denies, limits, or refuses an inspection • FDA Guidance, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” (Oct. 2014) • Delay – Postpones the start of an inspection without reasonable explanation – Leaves the investigator without access to requested documents or personnel for unreasonable time • Limiting – Discontinues manufacturing during inspection or limits direct observation without reasonable explanation – Prohibits photography without reasonable explanation – Unreasonably redacts requested documents 12

Inspections: Pathway to CFG Issuance (FDARA § 704) • FDA must provide a written explanation of the basis for a CFG denial • Identify the finding upon which the denial is based • For denials based on QSR non-compliance, include a substantive summary of the specific grounds for noncompliance – Unless basis is injunction, seizure, Class I or II recall • Prohibits CFG denials based solely on 483 observations if the firm “has agreed to a plan of correction” • Requires process for a review of CFG denials • Firms can request a review and submit new information, including evidence of corrective actions to address the identified non- compliance • Requires draft guidance by August 18, 2018 13

Inspections: International Recognition (FDARA § 705) • Adds statutory permission for FDA to “recognize” auditors usedby organizations established by foreign governments • Improve international harmonization of inspection standards • Increase FDA access to audit data • FDA retains ability to classify inspections • Related: FDARA § 703 reauthorizes FDA’s ability to conduct inspections via accredited organizations through 2022 14

Pediatric Devices (FDARA § 502) • Extends for five years the ability to sell pediatric Humanitarian Use Devices for more than the development and production cost of the device • Until October 1, 2022 (unless extended again before then) • Requires FDA to hold a public meeting to discuss thedevelopment, approval, or clearance and labeling of pediatric medical devices • Scheduled for August 13-14, 2018 – Registration open until August 6 – Meeting will be webcast – More details here: https://www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm596777.htm 15

Medical Device Accessories: Alternative Pathway to Market (FDARA § 707) • Pathway for classification and reclassification of accessories based on the accessory’s risk, not the parent device • Initial classification: may request separate classification of parent device and accessories in 510(k) or PMA submission • Reclassification: may request reclassification of accessories already approved or cleared under a parent device’s PMA or 510(k) – FDA must provide opportunity to meet before submission of written request – FDA must respond to the request within 85 calendar days • If FDA denies the request, must include a detailed justification • Must publish granted reclassifications in the Federal Register within 30 calendar days https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm5 89858.htm • Every 5 years, FDA must publish a proposed list of Class I accessory types 16

Report on Quality, Safety and Effectiveness of Servicing Medical Devices • FDARA Section 710 charged the Secretary to issue a report on the continued quality, safety and effectiveness of medical devices with respect to servicing that was published May 15, 2018, on its due date • Report as an outcome of March 4, 2016 FR Announcement requesting comment on “Refurbishing, Rebuilding, Remarketing and Servicing of Medical Devices mostly by third party providers • FDA held open public workshop on October 27-28, 2016 on the same topic. • Based upon information presented as well as other objective evidence available to FDA, they concluded: • The currently available objective evidence is not sufficient to conclude whether there is widespread public health concern related to servicing including by third party providers that would justify imposing additional/different regulatory requirements • Objective evidence reviewed indicated to FDA that both OEMs and third party providers provide high quality, safe and effective servicing • FDA did not find objective evidence to conclude there is a widespread public health concern related to servicing provided by third party providers.