FDA의 최근 규제 혁신에서 무엇을 배워야 하는가

Innovation of Regulation to Regulate Innovation

FDA의 최근 규제 혁신에서 무엇을 배워야 하는가
Director, Digital Healthcare Institute

Professor, Department of Digital Health, SKKU

Yoon Sup Choi, PhD

•2017년 7월 28일 FDA Center for Devices and Radiological Health (CDRH)가 발표

•새로운 디지털 헬스케어 기술/제품 등을 어떻게 규제할 것인지에 대한 액션 플랜 제시
Digital Health Innovation Action Plan
Introduction
FDA’s Center for Devices and Radiological Health (CDRH) puts patients at the forefront of our
vision—we are driven by timely patient access to high-quality, safe and effective medical
technology.
From mobile medical apps and fitness trackers, to software that supports the clinical decisions
doctors make every day, digital technology has been driving a revolution in health care.
This Digital Health Innovation Action Plan outlines our efforts to reimagine FDA’s approach for
assuring that all Americans, including patients, consumers and other health care customers have
timely access to high-quality, safe and effective digital health products. This plan lays out the
CDRH’s vision for fostering digital health innovation while continuing to protect and promote
the public health, including:
· Issuing guidance to provide clarity on the medical software provisions of the 21st
Century
Cures legislation;
· Launching an innovative pilot precertification program to work with our customers to
develop a new approach to digital health technology oversight (FDA Pre-Cert for
Software); and
· Building FDA’s bench strength and expertise in CDRH’s digital health unit.
Background
Digital health technologies can empower consumers to make better-informed decisions about
their own health and provide new options for facilitating prevention, early diagnosis of life-
threatening diseases, and management of chronic conditions outside of traditional care settings.
Software and technologies that assist in diagnosis, treatment options, storing and sharing health
records, and managing workflow can enable more efficient clinical practice. With advances in

배경
•균형적 의료기기 규제의 중요성과 어려움

•지나치게 높은 규제: 효율적 기술 혁신 및 환자의 ‘적시’ 수혜 저해

•지나치게 낮은 규제: 안전성과 효과성 증명이 부족한 기술의 출시 
•더욱 커지는 의료기기 규제의 어려움

•폭발적인 기술 발전: FDA의 규제 역량이 기술 발전을 따라가지 못함

•‘Medical Device’ 의 범주 확대

•기존의 하드웨어 의료기기의 범주에 들어가지 않는 의료기기의 등장

•SaMD (Software as a Medical Device)의 등장: 앱, 인공지능, 클라우드 등등
환자의 피해

SaMD WG (PD1)/N41R3
PROPOSED DOCUMENT
International Medical Device Regulators Forum
Title: Software as a Medical Device (SaMD): Clinical Evaluation
Authoring Group: Software as a Medical Device Working Group
Date: 5 August 2016

FDA의 문제 인식
•디지털 헬스케어 기술 혁신

•환자와 소비자들이 자신의 건강에 대한 결정권을 가지도록 empowering

•전통적인 의료 환경 외에서의 질병 예방, 조기 진단, 만성질환 관리가 가능

•SW와 technology로 더 효율적 진료, 치료, 진료기록 저장/공유 가능 
•디지털 헬스에 대한 FDA의 기존 규제의 문제

•FDA의 전통적인 규제 방식의 부적합성

•moderate/higher hardware-based medical device 규제는  
 
software-based 기술의 faster iterative design, development, validation에 부적합

•기존의 premarket requirement는 SW 기술 발전과 patients access에 방해

•따라서, 보다 efficient & risk-based approach 필요

“FDA의 전통적인 의료기기 심사 기준은 새로운 종류의 의료기기 심사에 적합하지 않다.”
“디지털 헬스케어의 특성을 인식하고, 양질의, 안전하면서도, 효율적인 혁신을 장려해야 한다.”
“우리는 규제의 개선을 통해 혁신을 장려해야 한다. 방해하는 것이 아니라.”
Scott Gottlieb, MD (FDA Director)

What FDA have already accomplished
•Digital Health Program 개설

•디지털 헬스케어 개발자, 환자, 병원의 관계 형성과 협력 장려

•규제 전략, 정책 등에 대한 도움을 통해 투명성, 명확성 강화 
•Digital Health 전담 부서 창설

•CDRH 내부에 별도 조직 “Digital Health Unit” (2017년 5월)

http://raps.org/Regulatory-Focus/News/2017/05/04/27484/FDA-to-Create-Digital-Health-Unit/

•지난 5년 간 한 일들

•모바일 메디컬 앱(MMA): higher risk 앱에 대해서만 규제하기로 결정

•MDDS (Medical Device Data System)

•데이터를 단순히 receive, transmit, store or display 하는 시스템에 대한 규제 완화

•기존 Class II 의료기기에서 Class I 으로 (2011), 다시 deregulation 으로 (2015) 조정

•General Wellness 기기에 대한 규제 명확화/완화

•Cyber security 관련 규제의 명확화

•FDA Safety and Innovation Act (FDASIA)를 통한 Health-IT 프레임워크 제시

https://www.youtube.com/watch?v=UR5t09mS8vk
Bakul Patel,Associate Center Director for Digital Health, FDA
Exponential Medicine, 2016

•International Medical Device Regulators Forum (IMDRF)

•Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, and USA

•work together to accelerate international medical device harmonization and convergence 
•Software as a Medical Device (SaMD)

•SaMD terminology, a risk classification schema

•application of quality management system principles tailored to software

•a guidance on application of clinical evaluation
SaMD WG (PD1)/N41R3
PROPOSED DOCUMENT
International Medical Device Regulators Forum
Title: Software as a Medical Device (SaMD): Clinical Evaluation
Authoring Group: Software as a Medical Device Working Group
Date: 5 August 2016

21st Century Cure Act
•아래와 같은 소프트웨어는 의료기기에서 제외

•환자의 의료 정보 또는 임상 연구 결과나 가이드라인 등의 의료 정보를 표시, 분석, 출력하는 소프트웨어

•질병 예방, 진단, 치료에 관해 의료 전문가에게 권고 사항을 지원하거나 제공하는 소프트웨어로

•의료전문가가 그러한 권고의 근거를 독립적으로 검토할 수 있도록 제작된 소프트웨어 
•다만, 의료 영상이나 체외 진단 기기로부터 나온 신호, 신호 획득 시스템으로부터 나온  
 
신호나 패턴 등을 획득, 처리, 분석하기 위한 경우에는 의료기기로 분류 
•위에 해당하는 비의료용 SW라도 다음에 관한 사실이 발견될 경우 FDA 관할 하에 둘 수 있음

•소프트웨어가 의도한대로 작동하지 않아 환자에게 위해를 끼칠 가능성이 있는 경우

•소프트웨어가 의료 전문가의 임상적 판단을 보장하지 않는 경우

•의료 전문가가 정보 또는 치료 권고의 근거를 검토할 수 있는 합리적 기회가 부여되지 않는 경우

•본래 제조자가 의도한 사용자와 사용 환경이 아닌 경우
SEC. 3060. “CLARIFYING MEDICAL SOFTWARE REGULATION.”

Real-World Evidence
Contains Nonbinding Recommendations
Use of Real-World Evidence to
Support Regulatory Decision-Making
for Medical Devices
Guidance for Industry and
Food and Drug Administration Staff
Document issued on August 31, 2017.
The draft of this document was issued on July 27, 2016
For questions about this document regarding CDRH-regulated devices, contact the Office of
Surveillance and Biometrics (OSB) at 301-796-5997 or CDRHClinicalEvidence@fda.hhs.gov.
For questions about this document regarding CBER-regulated devices, contact the Office of
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

•Real-World Data (RWD)

• 전통적인 임상 시험 ‘밖의’ 소스에서 얻어진 데이터

• retrospective database studies, case report, EMR,

• public health surveillance, registries etc…

• 의료/건강 관리 진행되면서 or 기기가 사용되면서 얻어지는 데이터 
• RWD가 의료기기 benefits/risk 및 환자와 병원에 대한 새로운 insight 제공 가능

• Verifiable source documentation for RWD elements includes,

• paper or electronic inpatient and outpatient medical records; case histories; 
 
diagnostic laboratory and imaging data; patient preference information;  
 
patient-reported outcome measures; UDI and other device identifiers;  
 
performance data that exist within the device such as self-diagnostics and  
 
error codes; patient diagnoses/treatments delivered 
Opportunities and Challenges  
in the Use of Real World Evidence  
for Medical Device and Drug Validation

•Real-World Evidence (RWE)

• RWD를 모으고 분석하여 이끌어낸 evidence. 
•어떠한 목적으로 활용될 수 있는가?

• Expanded indications for use

• 허가 받은 indication 외의 용도로 사용되고 있는 기기의 경우,  
 
환자의 데이터를 체계적으로 축적하여 안전과 효용을 평가 가능

• 이를 통한 labeling 의 확장 가능

• Postmarket Surveillance Studies

• Post-Approval Device Surveillance as Condition of Approval

• Control Group

• Supplementary Data
Opportunities and Challenges  
in the Use of Real World Evidence  
for Medical Device and Drug Validation

•21st Century Cure Act 하에서 SW 에 대한 다른 가이드라인과  
 
정책들의 consistency 및 clarity 강화 
• General 21st Century Cures Implementation Guidance

• Clinical Decision Support Software (CDSS)

• Multifunctionality

• Finalize guidance on Deciding When to Submit a 510(k) for  
 
a Software Change to an Existing Device

• Finalize the IMDRF approach to clinically evaluating SaMD 
1. Issuing new guidance implementing legislation

2. Reimagining digital health product oversight
무엇을 규제할 것인가?
기기

무엇을 규제할 것인가?
기기 제조사

•디지털 헬스케어 제품(product)가 아닌, 개발사(developer) 기반 규제

• 적절한 자격 요건을 갖춘 회사에 “자격(pre-certify)”을 부여

• 이 제조사의 디지털 헬스케어 제품은 pre-market submission을 면제받거나,  
 
인허가 과정을 간소화, 빠른 속도의 review 가능 
•제조사와 환자의 win-win

• 자격 요건을 갖춘 제조사들은 보다 큰 자율권을 가지고 자신의 기술을  
 
제품으로 만들어, 시장에 더욱 빠르게 출시 가능

• 환자들은 혁신의 결과물을 적시에 수혜 가능

Software Precertification Program: Working Model – Version 0.1 – April, 2018
Challenge questions for the Precertification Program:
FDA proposes the following challenge questions for public input.
Table 1. Example of Anticipated Program Benefits
End user Business FDA Payor Investor
Patients,
Providers,
Caregivers
SaMD
Developer
Agency
Reviewer
Insurance
Provider
Venture
Capitalist
Enhanced trust in organizations
developing SaMD products
+ + + +
Improved
quality/safety/proactiveness to
address known and emerging
risks
+ + + +
Timely availability of solutions
to patients
+ + + + +
Enhanced regulatory simplicity
and experience
+ + + +
Business simplicity -
faster/timely market access
+ + + +
Anticipated Program Benefits

개발 ➞ 임상시험 ➞ 데이터 ➞ 인허가 ➞ 출시
개발 ➞ 출시 ➞ 데이터(RWD)
기존 & 신규(Pre-certify 받지 못한 제조사)
신규(Pre-certify 받은 제조사)

advanced analytics to data tailored to the unique data needs and innovation cycles of medical
devices. The goal of NEST is to generate better evidence for medical device evaluation and
regulatory decision-making throughout the device innovation cycle.7
FDA is also considering
the role of third party certification in facilitating FDA determinations about pre-certification.
Figure 1. High level concept of the reimagined approach using FDA Pre-Cert for Software
The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a
program that can help reduce the time and cost of market entry for software developers that
FDA determines reliably manufacture high-quality, safe and effective digital health devices
while providing appropriate patient safeguards. Applying such an approach could improve
support for continued innovation, allow for more rapid availability of new and updated software,
and better focus FDA resources on higher-risk developers and products.
The Federal Register notice announcing the Software Pre-Cert Pilot Program with more details
Commercial
Distribution
& Real-
World Use
e.g. lower-risk software,
certain modifications
Real World
Data
Collection
Based on
SaMD Risk +
Pre-Cert
level Streamlined
Premarket
Review
FDA Pre-Cert
Level
•Pre-cert 취득 및 출시 이후에 Real-World Data 의 축적 가능

• 추가적 인허가 절차를 위한 RWD의

• 신규 기능 및 개선을 위한 RWD
Pre-certify 덕분에 RWD의 활용도 높아짐

결과적으로 신규 기기의 인허가에도 활용

3. Growing our expertise
•디지털 헬스케어에 대한 FDA의 전문성을 더욱 강화

• FDA가 현재의 디지털 헬스케어 산업 및 기술 발전을 f/u 하지 못하고 있을 인정

• 새로운 전문가 확충 + 재원 확충을 통한 전문성 강화

• 규제적 판단의 질, 예측가능성(predictability), 일관성(consistency), 적시성 
 
(timeliness), 효율성(efficiency) 강화 
•EIR(Entrepreneurs in Residence, 초빙 기업가) 프로그램 운영

• 업계의 리더들(thought leaders)과 소프트웨어 개발에 실제 경험이 있는  
 
‘외부’ 전문가들로부터 도움을 받아서 CDRH (Center for Devices and  
 
Radiological Health)의 전문성을 강화

Successful candidates will be talented, innovative, out-of-the-box thinkers with industrial
experience that are capable of providing technical expertise in one or more of the
following digital health focus areas:
software lifecycle management processes, mobile medical apps, medical device
interoperability, healthcare cybersecurity, wireless technologies, cloud-enabled software
deployment, machine learning/artiﬁcial intelligence, big data

Pilot of Pre-Cert Program
•파일럿 시행 (8월 1일 모집 시작)

• 9개의 기업을 먼저 선정하여 pre-certify 정책을 테스트

• 저위험-고위험 SW의 제조사, 다양한 규모의 제조사 모두 포함 예정 
•파일럿 참여 기업의 조건

• 의료기기에 해당하는 소프트웨어를 개발하고 있거나 개발할 계획이 있어야 한다

• 소프트웨어 개발, 테스트, 유지에 대한 수치적으로 검증된 역량과 경험을 보유

• 이 파일럿 기간 동안 회사들은 아래의 부분에 동의해야 한다.

• Real-world post-market data 를 수집하고 이를 FDA에 제공

• 실시간 상담을 위해 FDA와 미팅

• FDA의 현장 점검이 가능할 것

Pre-Cert 파일럿 참여 기업 9개 선정

(2017.9.26)
• Apple
• Samsung
• Verily (Google) 
• Johnson & Johnson
• Roche 
• Fitbit
• Pear Therapeutics
• Phosphorus 
• Tidepool
대형 IT 기업
의료기기/제약사
헬스케어 스타트업
비영리 (1형 당뇨)
총 103개의 지원 기업 중에,

다양한 규모의 조직

다양한 위험도의 의료기기 포괄

https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm587581.htm
https://tidepool.org/fda-precert-pilot-program-public-workshop/
Public Workshop - Fostering Digital Health Innovation:
Developing the Software Precertification Program

(2018. 1. 30-31)

https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm587581.htm
https://tidepool.org/fda-precert-pilot-program-public-workshop/
Public Workshop - Fostering Digital Health Innovation:
Developing the Software Precertification Program

(2018. 1. 30-31)
“But making tangible progress with 400+ people is tricky, even with breakout sessions. I was very glad that the pilot program
participants were asked to stay an extra day to spend quality in-person time with the other pilot participants. This was an
incredibly productive day, and I left very conﬁdent in this group’s ability to collaborate effectively and productively.”

Developing a Software Precertification
Program: A Working Model
(v0.1- April 2018)
Introduction
The Software Precertification Program is envisioned as a voluntary pathway that embodies a
regulatory model more tailored than the current regulatory paradigm to assess the safety and
effectiveness of software technologies without inhibiting patient access to these technologies.
The program is envisioned to provide a more streamlined and efficient regulatory oversight of
software-based medical devices from manufacturers who have demonstrated a robust culture of
quality and organizational excellence (CQOE) and committed to monitoring real world
performance. The current vision for this regulatory model is described in this paper. This paper
also sets out challenge questions for public comment, which will be incorporated into future
updates of this working model that FDA will continue to periodically release for public input.
This pilot precertification program is an important first step to help us explore and evaluate the
program model to inform how we establish the precertification program. Once we determine the
elements for a future precertification program, we will then consider appropriate mechanisms for
establishing the program, including FDA's current statutory and regulatory authorities.
Software is increasingly used in healthcare to promote wellness, treat and diagnose disease,
aid clinical decision making, and manage patient care. The ability to download these software
programs onto ubiquitously connected mobile platforms allows them to be used in the hospital
and in the home, by clinicians and patients. Historically, healthcare has been slow to implement
technology tools that have transformed other areas of commerce and daily life. One factor that
has been cited, among many, is the regulation that accompanies medical products. But
momentum toward a digital future in healthcare is advancing. FDA oversees most mobile apps
that are intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions as
medical devices under Federal statute. These software-based technologies, including mobile
medical apps, are what FDA and other regulators call “Software as a Medical Device” (SaMD).
FDA’s traditional approach for the regulation of hardware-based medical devices is not well-
suited for the faster, iterative design, development, and type of validation used for SaMD. SaMD
products offer unique opportunities, such as addressing malfunctions quickly and efficiently to
minimize adverse events, understanding and capturing patient performance outside of the
clinical setting, and enabling patient engagement. Unlike manufacturers of hardware devices
who modify their products every few months to years, developers of SaMD modify their products
in response to real world performance and user feedback every few weeks to months.
Furthermore, evaluating software code alone may not provide a full understanding of the safety
and effectiveness of a SaMD product, in part because the impact on patients is often indirect.
As a result, the application of FDA’s longstanding regulatory framework to SaMD can impede
access to new and improved software-based medical products. An agile regulatory paradigm is
necessary to accommodate the faster rate of development and potential for innovation in
software-based products. It is important for public health to address these distinctive aspects of

•배경

•“FDA’s traditional approach for the regulation of hardware-based medical devices is
not well suited for the faster, iterative design, development, and type of validation
used for SaMD.”

•Unlike manufacturers of hardware devices who modify their products every few
months to years, developers of SaMD modify their products in response to real world
performance and user feedback every few weeks to months.

•As a result, the application of FDA’s longstanding regulatory framework to SaMD
can impede access to new and improved software-based medical products

•어떤 기업을 찾나

•SaMD를 시장에 출시 한 이후에도 RWPD에 기반하여 기기를 잘 모니터링하고 관리,  
수정/업데이트할 경험과 역량이 있는 회사

•The assessment of organizations that perform high-quality software design, testing, and
monitoring; based on demonstration of a culture of quality and organizational excellence
and a commitment to monitor ongoing performance

•The Software Pre-certification Program is envisioned to evaluate a firm’s capability to
respond to real world performance, and FDA intends to work with pre-certified firms to
quickly and effectively address software issues.

•Excellence Principles

•FDA will evaluate organizational excellence based on  
5 culture of quality and organization excellence (CQOE) principles

•Product Quality

•Patient Safety

•Clinical Responsibility

•Cybersecurity Responsibility

•Proactive Culture

•In addition to CQOE, precertified organizations will also have,

•a robust mechanism to collect, monitor, and analyze real world performance of
their organization and the products they deliver

•Excellence Principles

•Product Quality: Demonstration of a commitment to the development, testing, and
maintenance necessary to deliver SaMD products at the highest level of quality.

•Patient Safety: Demonstration of a commitment to providing a safe patient experience,
and emphasizing patient safety as a critical factor in all decision-making processes.

•Clinical Responsibility: Demonstration of a commitment to responsibly conduct clinical
evaluation and ensure that patient-centric issues including labeling and human factors
are appropriately addressed.

•Cybersecurity Responsibility: Demonstration of a commitment to protect cybersecurity,
and to proactively address cybersecurity issues through active engagement with
stakeholders and peers.

•Proactive Culture: Demonstration of a commitment to a proactive approach to
surveillance, assessment of user needs, and continuous learning.

Software Precertification Program ComponentsSoftware Precertification Program: Working Model – Version 0.1 – April, 2018
Figure 1. Software Precertification Program Components
Component 1: Excellence appraisal and precertification
The principal objective of the excellence appraisal and precertification component is to develop
the process of company precertification, including eligibility and application, evaluation against
precertification criteria, and precertification status determination.
Eligibility
1) Excellence appraisal and precertification

2) Review pathway determination

3) Streamlined premarket review

4) Real world performance (PMS of SaMD and feedback into the pre-cert program)

Component 1: Excellence appraisal and
precertification
•Eligibility

•인허가 대상인 SaMD를 개발하고 판매하려고 하는 미국의 조직

•Initial Precertification: 5 CQOE

•Product Quality; Patients Safety; Clinical Responsibility; Cybersecurity Responsibility; Proactive Culture

•Precertification levels

•Level 1 Pre-Cert: 기존에 SaMD를 출시한 경험이 없거나 제한적인 조직

•Level 2 Pre-Cert: 기존에 SaMD나 의료기기를 출시한 트렉 레코드가 있는 조직

•Maintenance and Monitoring of Pre-Cert Status

•FDA expects that maintaining Pre-Cert status will be automatable

•Organizational leadership will track and monitor its adherence to the excellence principles

•관련한 디테일은 추후 구체화될 예정

Component 2: Review pathway determination
The IMDRF issued a framework for risk-based clinical evaluation of the safety and effectiveness
of SaMD, which FDA adopted as a guidance document.2
That framework includes Table 2,3
designed to facilitate harmonized risk categorization of SaMD, based on intended use.
Table 2. IMDRF type (I to IV) and subtype (1 to 9) of SaMD products by state of healthcare
condition and significance of information provided by the products to healthcare decision.
State of Healthcare
situation or
condition
Significance of information provided by SaMD
to healthcare decision
Treat or
diagnose
Drive clinical
management
Inform clinical
management
Critical IV (9) III (7) II (4)
Serious III (8) II (6) I (2)
Non-serious II (5) I (3) I (1)
In order to determine where a SaMD falls in the IMDRF risk-categorization table, a SaMD
manufacturer should characterize the SaMD’s intended use as a “SaMD definition statement”
(see box below) as defined in the "Software as a Medical Device": Possible Framework for Risk
Categorization and Corresponding Considerations IMDRF N12 document.4
The SaMD definition statement should include a clear and strong statement about intended
use, including the following:
A. The “significance of the information provided by the SaMD to the healthcare
decision” which identifies the intended medical purpose of the SaMD. The statement
should explain how the SaMD meets one or more of the purposes described in the
IMDRF type (I to IV) and subtype (1 to 9) of SaMD products by
state of healthcare condition and significance of information
provided by the products to healthcare decision.
SaMD에서 나온 정보가

의학적 의사결정에

얼마나 중요한 영향을 미치는가
적용 대상의

의학적 상태나 조건

Component 1+2: model for determining
premarket review pathway
This is an important first step to help us explore and evaluate the program model to
inform how we establish the Precertification Program. Once we determine the elements
for a future Precertification Program, we will then consider appropriate mechanisms
for establishing the program, including FDA's current statutory and regulatory
authorities. While the FDA has not yet determined the appropriate method for
determining review pathway, the detailed information in this box reflects current
thinking subject to public feedback and iteration.
The table below lays out an initial model for determining premarket review pathway for SaMD
from precertified companies, depending on (1) the IMDRF risk category of the SaMD, (2) the
level of precertification of the organization, and (3) whether the SaMD is a new device or an
iteration of an existing device, as follows:
Table 3. Level of Review for Level 1 and Level 2 Precertified Organizations’ SaMD
IMDRF Risk Categorization
Level of Review for Level 1 and Level 2
Precertified Organizations’ SaMD
Type
Sub
type
Description Initial product Major changes Minor changes
Type
IV
(9) Critical x diagnose/treat
SR SR No Review
Type III (8) Critical x drive
SR
L1 – SR
L2 – No Review
No Review
Type III (7) Serious x diagnose/treat
SR
L1 – SR
L2 – No Review
No Review
Type II (6) Serious x drive L1 – SR
L2 – No Review
L1 – SR
L2 – No Review
No Review
Type II (5) Non-serious x
diagnose/treat
L1 – SR
L2 – No Review
No Review No Review
Type II (4) Critical x inform L1 – SR
L2 – No Review
No Review No Review
Type I (3) Non-serious x drive No Review No Review No Review
Type I (2) Serious x inform No Review No Review No Review
Type I (1) Non-serious x inform No Review No Review No Review
This table describes when the precertification of organizations and commitment to leverage
real world performance replaces the need for a premarket submission (no review) or allows
for streamlined premarket review (SR), according to the IMDRF type/subtype of the SaMD
and the Pre-Cert Level of the organization (L1, Level 1; L2, Level 2).
The table below lays out an initial model for determining premarket review pathway
for SaMD from precertified companies, depending on
(1) the IMDRF risk category of the SaMD
(2) the level of precertification of the organization (L1, L2)
(3) whether the SaMD is a new device or an iteration of an existing device
SR: streamlined premarket review
The Pre-Cert Level of the organization (L1, Level 1; L2, Level 2).

Component 4: Real world performance
FDA will continue to build and refine this working model by incorporating comments received, as appropriate, and
will regularly seek additional public input throughout the development of this program. 14
For the purposes of this document, real world performance data (RWPD) is defined as all data
relevant to the safety, effectiveness, and performance of a marketed SaMD product from a
precertified manufacturer. FDA anticipates that RWPD may be generated efficiently by
leveraging not only data collected from appropriately instrumented SaMD products, but also real
world data from device registries, and other electronic health information sources including the
National Evaluation System for health Technology (NEST), which is currently under
development.
FDA considers RWPD to encompass at least three types of data (Figure 2), as defined below.
Figure 2. Relationship between various types of SaMD RWPD outputs and outcomes
Real World Performance Data (RWPD)
Real World
Health Data
(RWHD)
User
Experience
Data (UXD)
Product
Performance
Data (PPD)
•Real world health data (RWHD)

•Outputs and outcomes related to the SaMD Definition Statement

•User experience data (UXD)

•Outputs derived from user experiences related to the real-world use of a SaMD product.

•Product performance data (PPD)

•Outputs and outcomes demonstrating the accuracy, reliability, and security of a SaMD product.

Component 4: Real world performance
•Framework for Use of RWPD

•Monitoring “ongoing” safety, effectiveness, and performance of marketed SaMD products.

•Supporting modifications of clinical and performance claims for safety and effectiveness.

•Providing input to initial precertification and changes to precertification status.

•Providing feedback to FDA to further refine the Pre-Cert Program appraisal model and streamlined review process.

FDA는 제조사 기반의 규제를

앞으로 더욱 확대할 계획

Results within 6-8 weeksA little spit is all it takes!
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FDA 블룸증후군

DTC 서비스 허가
FDA에 블룸증후군

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질병위험도 검사

DTC 서비스 허가

+

관련 규제 면제

프로세스 확립
Digital Healthcare Institute
Director,Yoon Sup Choi, PhD
yoonsup.choi@gmail.com
FDA

Pre-Cert
FDA Gottlieb 국장,

질병 위험도 유전자

DTC 서비스의

Pre-Cert 발의
200만 명 돌파

• 개별 제품이 아닌 제조사 기반의 규제를 유전자 DTC 검사에도 적용하는 방안
• Gottlieb 국장:
• “23andMe의 규제 과정을 거치면서 FDA도 많이 배웠다”
• 질병 위험도 DTC 검사를 '한 번' 인허가 받은 회사의 후속 검사는 규제 면제 추진
• 한국의 유전자 DTC 규제 방식과의 괴리는 더욱 커질 전망

•기존에 Class III 로 관리되었던 CADx가 “암의 의심 병변을 찾아내는 목적”에 한해서 Class II 의료기기 
 
로 하향조정 (2017. 7. 19)

•"Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer”

•by Center for Devices and Radiological Health (CDRH)

•Quantitative Insights의 QuantX라는 CADx 기기의 classification의 de novo request 에 대한 결정

•여타 목적의 CADx 에 대해서도 향후 영향을 미칠 수도 있을 것으로 예상
https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170022.pdf
인공지능 의료기기에 대한 FDA의 규제 완화
이러한 방식 자체가 이미 ‘과거’의 규제 방식

https://twitter.com/SGottliebFDA/status/984116873901076480?mc_cid=35d3b087e4&mc_eid=ea6f4a2940
인공지능 의료기기에도 Pre-Cert 적용 예정

• FDA Commissioner Dr.Scott Gottlieb
• 인공지능 의료기기의 인허가에 Pre-Cert 방식을 적용하겠다는 계획 재차 강조
• Pre-Cert가 SaMD 의 잦은 업데이트와 변경에도 그때마다 새롭게 인허가를  
 
 
다시 받지 않아도 되게 해주겠다는 것에서 출발한 것이기 때문에,  
 
 
인공지능 기반 의료기기를 규제하기에 적합

Potential Pitfalls of Pre-Cert Program
• 세부적 운영 방식에 따라서 제도의 성패가 크게 차이날 수 있음

• 우려: Pre-Cert로 인해 오히려 FDA의 권한이 강화될 수도 있음

• SaMD의 approval과 시장 진출은 가속화될 수 있지만,

• 대신, 출시 이후에 개발사에 대한 FDA의 모니터링과 간섭이 오히려 강해질 수도

• 다분히 정성적인 기준인 5 CQOE 의 공정한 적용이 가능한지도 관건

• 파일럿이 파일럿이 아님..

• 세부 기준을 확립 후에 파일럿 기업에 적용하는 것이 아니라,

• 파일럿 기업을 뽑은 후에야, 세부적인 사항들을 확립하고 있음

• 규제 대상자 (대기업, 스타트업, 비영리 등)의 목소리를 듣는다는 것은 긍정적

Summary
•디지털 헬스케어 분야의 특수성과 파급 효과를 인식

• 기존의 규제 방식이 적합하지 않음에 대한 인식

•SaMD: 소프트웨어 의료 기기에 대한 규제의 발빠른 개선

• MMA, SaMD, RWD, 21st Century Cure Act

• 규제의 질, 명확성, 일관성, 효율성, 적시성 강화

•Pre-Cert: 제조사 기반의 새로운 규제 프레임워크

• 현재 파일럿을 시행하면서 세부 조건을 만들어가는 과정

• 이를 추진할 독립적 부서, 전문 인력, 재원을 확보하고 있음

•유전자, 인공지능 등에 대해서도 Pre-Cert 방식 적용 예정

•Pre-Cert의 디테일은 계속 만들어가는 과정 (악마는 디테일에..)

제언
•식약처의 전문성의 양적, 질적 강화

• 디지털 헬스케어 및 의료 혁신 전담 인력의 절대적 부족

• 전담 부서의 개설 및 외부 전문성의 적극적 도입 필요

•네거티브 규제의 도입

• 혁신은 어디에서 무엇이 나올지 모르기 때문에 혁신

• 최소한 규제가 혁신을 방해하지는 않아야

•국내 규제와 글로벌 규제와의 alignment

• 국내는 글로벌 규제와의 괴리가 심화된 규제 갈라파고스

• 규제 괴리는 산업 성장에 큰 걸림돌

•기업의 자율성 강화 & 정부의 역할을 최소화하는 규제

• 혁신적 기술의 가치 및 필요성을 국가가 산정한다는 것은 어불성설

• 문재인케어가 의료 혁신 및 기술 발전을 저해하지 않기 위한 방안 필요

한 나라의 의료 산업 수준은

그 나라의 규제 수준이 결정한다.
최윤섭, PhD

yoonsup.choi@gmail.com

FDA의 최근 규제 혁신에서 무엇을 배워야 하는가

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