evolving regulatory pathways for medical devices...ctq pilot program - overview •voluntary...

2018 FDLI Annual Conference | Access materials at fdli.org/annual2018

Evolving Regulatory Pathways for Medical Devices


Key Themes

Evolving Regulatory Pathways

Least Burdensome

Culture of Quality

Adaption to Novel and

Fast-Evolving Technology

Quality System

Maturity


Heading Overview

• Deciding When to Submit a 510(k) for a Change to an Existing Device

• Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria

• Digital Health Pre-Certification Pilot Program• PMA Critical to Quality (CtQ) Pilot Program• New “Least Burdensome” Guidance• Combination Product Process• Additional Areas of Evolution in Device Regulation• A Policy Perspective


Deciding When to Submit a 510(k) for a Change to an Existing Device

• Required when a change could significantly affect safety or efficacy

• Not intended to implement significant policy changes

• Intended to enhance predictability, consistency and transparency in the process


Deciding When to Submit a 510(k) for a Change to an Existing Device

• Adds clarity regarding when changes to indications require a new 510(k)

• Added a risk based assessment approach

• FDA also released a separate guidance regarding deciding when to submit a 510(k) for a software change


Demonstrating Substantial Equivalence through Performance Criteria

• Intended for well-understood device types

• Allow applicants to demonstrate safety and efficacy by meeting FDA-identified performance criteria

• Direct head-to-head comparisons against predicate devices would not be required to demonstrate substantial equivalence


Demonstrating Substantial Equivalence through Performance Criteria

• FDA to maintain a list of device types appropriate for the program

• FDA to issue additional guidance on specific performance criteria


Digital Health Software Precertification Pilot Program

• GOAL: Develop an organization-based streamlined regulatory approach for software as a medical device (SaMD) that relies on a demonstrated culture of quality and organizational excellence

• Nine participants selected: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily

• Program in development through the end of 2018


Envisioned Pre-Cert Process

• Assess company’s SaMD Risk• Complete the company’s Pre-Cert Scorecard• Based on results, a company’s new software will

either undergo a streamlined pre-market review, or will be allowed to go straight to market

• Real world data collection will take place• FDA will collect feedback and revise assessment

process


Pre-Cert Scorecard• Pre-Cert Scorecard currently being developed in workshops with 9

program participants• Based on Five Excellence Principles:

– Patient Safety– Product Quality– Clinical Responsibility– Cybersecurity Responsibility– Proactive Culture

• Using Appraisal Tools:– Key Performance Indicators– Appraisal methodology, tools and criteria– Definition of tiers, criteria and thresholds


CtQ Pilot Program - Overview

• Voluntary Premarket Approval Application (PMA) program

• Open to first 9 eligible applicants through 12/31/2018

• GOAL: To promote quality in device design and manufacturing and to streamline the PMA process

• PROCESS: No preapproval inspections. Instead, post-approval inspections will take place.


CtQ Pilot Program - Requirements

• Submit a request for a pre-PMA q-submission meeting and state interest in the program

• Submit PMA and streamlined process validation report

• Required: Current inspections, with no Official Action Indicated findings

• Required: No Quality System Deficiencies identified in PMA review


CtQ Pilot Program - Status

• Little public information available on status of pilot program

• In December 2017, United Health Products, announced that its product, HemoStyp, a hemostatic gauze, was accepted as first participant in program


FDA Guidances

• The Least Burdensome Provisions: Concept and Principles – Draft; issued on 12/15/2017; comments closed; to supersede prior

guidance issued on 10/4/2002

• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions– Final; issued on 9/29/2017; supersedes prior guidance issued on

11/2/2000

• Statutory bases: Food and Drug Administration Modernization Act (FDAMA) (1997); Food and Drug Administration Safety and Innovation Act (FDASIA) (2012); 21st Century Cures Act (2016)


New Definition of “Least Burdensome”

• Old – “a successful means of addressing a premarket issue that involves the most appropriate investment of time, effort and resources on the part of industry and FDA”

• New – “the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time (e.g., need to know versus nice to know)”


“Least Burdensome” Guidance - Scope• All devices

• All activities (including premarket and postmarket actions) regarding the regulation of medical devices, including:

– Premarket submissions

– Additional information and major deficiency letters

– Q-submissions

– Informal/interactive inquiries regarding device development

– Panel review and recommendations

– Postmarket surveillance and post-approval studies

– Reclassifications and exemptions

– Guidance documents

– Compliance-related interactions

– Regulation development


“Least Burdensome” Guidance – Guiding Principles• Minimum information necessary

• Less burdensome sources of clinical data (e.g., RWE, literature, OUS data)• Non-clinical data• Alternative approaches

• Most efficient means to resolve issues• Reduce burden of traditional clinical studies

(e.g., historical control groups, registry data)• Use benefit-risk assessments• Streamline processes and reduce

administrative burden• Global harmonization

• Just-in-time data collection• Balance pre- and post-market information needs


“Deficiency” Guidance

• All deficiency letters – to include a statement of the basis for the deficiency

– to undergo supervisory review prior to issuance

• Guiding principles– Exclude information unrelated to the regulatory decision

– Consider alternative approaches to optimize the necessary time, effort and resources involved in developing a response

– Request the minimum amount of information necessary

– Only include major deficiencies that require resolution prior to a final decision on marketing authorization


Combination Product Process

• FDA working to improve combination product review process – most notably inter-center consults

• Changes under 21st CC and FDARA for combination products, especially in process

• Pain points still exist: human factors, different data standards for drugs and devices, inconsistency of review


Hatch-Waxman for Combination Products Using an Already-Approved Constituent Part

• 21st Century Cures created new requirements for device PMOA combination products that have a drug constituent part that is already approved

• the sponsor must:– submit a patent certification – PI - PIV.– The 30-month stay applies if suit is timely brought.

• Exclusivities for the drug also block approval of the combination product.


Additional Areas of Evolution in Device Regulation

• Breakthrough Devices

– Getting innovative devices to market

• Accessories

– Change in classification process for accessories

• Regulation of NGS and DTC Tests


A Policy Perspective

– Joni to insert

evolving regulatory pathways for medical devices...ctq pilot program - overview •voluntary...

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