Confiden'al
FDA Regula+ons and Medical Device Pathways to Market
Russ King President (919) 313-‐3962 [email protected]
The contents of this presentation is not intended as and should not be interpreted as regulatory advice for any specific product or company.
Confiden'al Medical Devices and the FDA
What is a Medical Device?
We know a medical device when we see it! Legal Defini'on: An instrument, apparatus, implant, in vitro reagent, or similar or related ar'cle that is used to diagnose, prevent, or treat disease or other condi'ons, and it is not a drug.
Confiden'al Medical Devices and the FDA
FDA as Regulators of Medical Devices
What is the Food and Drug Administra+on • Regulatory Body i.e. a law enforcement agency • FDA enforces administra've laws designed to ensure product
efficacy and public safety. Examples of FDA regula'ons: • FDA Product Approval Processes (e.g. 510(k) approval) • 21 CFR Part 820 or Good Manufacturing Prac'ces (GMPs) • 21 CFR Part 11 for cri'cal SoYware
• Other Administra've Laws you have heard of: • Tax Law • Immigra'on Law • Trade Law
• As a law enforcement agency, the FDA approves for the US Market products subject to FDA over site and when applicable laws are violated the FDA can cite, fine and prosecute for viola'ons of laws
Confiden'al Medical Devices and the FDA
FDA as Regulators of Medical Devices
The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for regula+ng medical devices
Confiden'al Medical Devices and the FDA
FDA as regulators of Medical Devices
Summary of FDA Approval • FDA risk based approval process:
• Class I: FDA Product Registra'on • Class II: Pre-‐Market No'fica'on – 510(k) • Class III: Pre-‐Market Approval – PMA
• Product approval requires a compliant Quality Management System (QMS)
• General Controls • General Controls & Special Controls
Class IIClass I Class III
Implement Quality Management System that meets FDA Quality System Regulation (QSR) as found in 21 CFR 820
Device may require clinical data
Develop clinical trial protocol and obtain FDA approval to conduct trial
FDA conducts facility inspections
Prepare and submit 510(k) application. Pay 510(k) Fee
Prepare and submit PMA for
completeness review.
Notified Body and/or FDA Reviews
510(k)
Prepare and submit PMA for
completeness review.
FDA issues 510(k) clearance letter
FDA issues PMA approval letter
Execute Commercialization Plan
Confiden'al Medical Devices and the FDA
Product Component of FDA Approval
The FDA Approval Path for Medical Devices Includes a Product Component and a Company Component • Product Component
• FDA uses a risk based classifica'on product approval process: The higher the risk, the higher the eviden'ary threshold for demonstra'ng product Safety and Efficacy
• Low Risk -‐-‐ Class I: FDA Product Registra'on • Tongue depressors, arm slings, and stethoscopes
• Medium Risk -‐-‐ Class II: Pre-‐Market No'fica'on – 510(k) • physiologic monitors, x-‐ray systems, gas analyzers, and pumps
• High Risk -‐-‐ Class III: Pre-‐Market Approval – PMA • pacemakers, replacement heart valves and total joint
replacements
Confiden'al Medical Devices and the FDA
Product Component of FDA Approval
Taking a Closer Look at the 510(k) Process • Theore+cal Founda+on: Instead of proving your device is safe and
effec've with clinical trials you can take a shorter path for product approval by demonstra'ng your device is just as safe and effec've as an already approved device (i.e. a predicate device) by showing it is substan'ally equivalent to a predicate device which has already been shown to be safe and effec've
• The 510(k) process is one which demonstrates the substan'al equivalence of an unapproved device to an already approved or predicate device
Confiden'al Medical Devices and the FDA
Product Component of FDA Approval
Establishing Substan+al Equivalence • Iden'fy similar device(s) that could serve as a predicate • A device is substan'ally equivalent if, in comparison to a
predicate it has: • The same intended use as the predicate; and • The same technological characteris'cs as the predicate;
Or • The same intended use as the predicate; and • Has different technological characteris'cs and the informa'on
submihed to FDA • Does not raise new ques'ons of safety and effec'veness;
and • Demonstrates that the device is at least as safe and as
effec've as the legally marketed device
Confiden'al Medical Devices and the FDA
Product Component of FDA Approval
De Novo: An Alterna+ve 510(k) Process • Theore+cal Founda+on: If your medical device has no substanailly
equivalent predicate device but you can clearly demonstrate that the risks posed by the device when used as intended does not rise above a moderate level of risk (i.e. show that the device is appropriately considered a Class I or Class II device), then the FDA may grant permission to file a de novo applica'on
• The de novo process is one which demonstrates the risk of the device when used as intended meets the risk posed by either a Class I or II device. The de novo process requires pre-‐submission mee'ng(s) with and permission from the FDA. Though de novo may represent a less expensive route to market than a PMA because it will not require clinical trials, it may require clinical and or performance data and the de novo process can add 6 to 18 months to the normal 510(k) clearance process
Confiden'al Medical Devices and the FDA
Company Component for FDA Approval
The FDA Approval Path for Medical Devices Includes a Product Component and a Company Component Company Component
• FDA requires all Medical Device companies to have a Quality Management System (QMS) that complies with Good Manufacturing Prac'ces (GMPs; 21 CFR Part 820)
• Low Risk -‐-‐ Class I: QMS with General Controls • Medium Risk -‐-‐ Class II: QMS with General Controls & Special Controls • High Risk -‐-‐ Class III: QMS with General Controls and PMA
Medical Devices and the FDA
General Controls General Controls & Special Controls Document Control Document Control Labeling / Packaging Control Labeling / Packaging Control Record Control Record Control Recall Management Recall Management Adverse Event / MDR Repor'ng Adverse Event / MDR Repor'ng Iden'fica'on /Traceability / Distribu'on
Iden'fica'on /Traceability / Distribu'on
Advisory No'ces Advisory No'ces Returned Products Returned Products Installa'on Installa'on
Design Controls Risk Management SoYware Valida'on Post Market Surveillance
Confiden'al
Company Component for FDA Approval
21 CFR Part 820: General vs. Special Controls
Medical Devices and the FDA
Confiden'al
Company Component for FDA Approval
A closer look at Design Controls • Establishing intended use and design inputs • A design plan • Periodic design reviews throughout the design process • Confirma'on that the design outputs conform to the design inputs
through design verifica'on ("Are we making the device according to the design?")
• Design valida'on (“Are we making the right device?") • Transla'on of the design into manufacturable specifica'ons • Clear documenta'on of the en're process in a design history file or
DHF
Confiden'al Medical Devices and the FDA
Important Considera+ons!
Do you need: • IEC 60601-‐1 3rd Edi'on Amendment 1
Safety Tes'ng? • IEC 62304 SDLC Documenta'on? • Clinical Data? • Clinical Trial? • Performance Data? • SoYware Valida'on per 21 CFR Part 11?
Class IIClass I Class III
Implement Quality Management System that meets FDA Quality System Regulation (QSR) as found in 21 CFR 820
Device may require clinical data
Develop clinical trial protocol and obtain FDA approval to conduct trial
FDA conducts facility inspections
Prepare and submit 510(k) application. Pay 510(k) Fee
Prepare and submit PMA for
completeness review.
Notified Body and/or FDA Reviews
510(k)
Prepare and submit PMA for
completeness review.
FDA issues 510(k) clearance letter
FDA issues PMA approval letter
Execute Commercialization Plan