FDA Reauthorization Act of 2017 (FDARA) April 4, 2018 PRESENTED BY: Jessica Ringel Counsel FDA & Life Sciences Practice Group King & Spalding LLP (202) 626-9259 jringel@kslaw.com
FDA Reauthorization Act of 2017 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 4
User Fees, FY 2018-2022 MDUFA III MDUFA IV (FDARA) Fee Type FY 2017 FY 2018 FY 2019 FY 2020 FY 2021 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 annual report $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 5
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 the previous 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 7
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 8
Inspections: Feedback (FDARA 702) New statutory requirement for FDA to provide feedback on a firm 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 9
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 10
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 11
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 noncompliance Requires draft guidance by August 18, 2018 12
Inspections: International Recognition (FDARA 705) Adds statutory permission for FDA to recognize auditors used by 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 13
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 the development, 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 14
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 15
Other FDARA Device Provisions 510(k) clearance or PMA approval for medical imaging devices when intended for use with a contrast agent in a manner different from that in the contrast agent s labeling (FDARA 706) Pilot projects to improve postmarket surveillance (FDARA 708) Establishment of a new category of over-the-counter hearing aids (FDARA 709) Report on FDA regulation of servicing devices (FDARA 710) 16
FDA Actions Required by FDARA Guidance Topic Deadline FDA Action? Report on FDA website re: servicing of devices May 15, 2018 Not yet Meeting on pediatric device development Aug. 18, 2018 Draft guidance on CFGs, explanation of denials and review process Draft guidance on inspection process, timeframes, and feedback Report to Congress on postmarket surveillance pilot projects Final guidance on regulatory requirements for hearing aids and personal sound amplification products Report to Congress on OTC hearing aid adverse events Third party review of the postmarket surveillance pilot projects Aug. 18, 2018 Feb. 18, 2019 Feb. 18, 2019 Date that final OTC hearing aid regs are issued 2 years after final OTC hearing aid regs Jan. 31, 2021 Scheduled for Aug. 13-14, 2018 On CDRH FY 2018 guidance development A list Not on CDRH FY 2018 guidance development list Not yet Not on CDRH FY 2018 guidance development list n/a n/a 17
Questions?