510(k) - Indiana Medical Device Manufacturers Council

Report
Premarket Processes & Pathways to
Market
Pre-amendment, Exempt, 510(k), and 513(g)
Chris Kilander – Cook Pharmica, LLC
15 May 2014
www.cookmedical.com
Medical Device Risk Classes
Risk
Class
Relative
Risk
Controls
Typical Marketing
Pathway
Examples
Class I
Low
General Controls
Exempt
Adhesive
bandage
Class II
Moderate General & Special Premarket
Controls
Notification, i.e.,
510(k)
Magnetic
resonance
imaging
system
Class III
High
Renal artery
stent
General & Special Premarket Approval,
Controls;
i.e., PMA
Premarket
approval
15 May 2014
Medical Device Risk Classes
•
General Controls (all classes):
– Establishment Registration & Device Listing (21 CFR 807, Subpart B)
– Quality System Regulation (21 CFR 820)
• Most Class I devices exempt from Design Control (21 CFR 820.30)
– Postmarket Medical Device Reporting (21 CFR 803)
– Premarket Notification (21 CFR 807 , Subpart E)
• Most Class I devices exempt from premarket notification
– Labeling (21 CFR 801)
•
Special Controls (Class II & III):
– Product-specific FDA guidance documents and/or recognized standards
– Premarket clinical studies
– Postmarket clinical studies/registries
15 May 2014
Classification Framework
• Classification based upon Intended Use
– Purpose for which the device is to be used
– Objective intent of the persons marketing the device
– vs. Indications for Use
• By default, medical devices are Class III, however:
– FDA may issue classification regulations
– Regulations indicate class and exempt or premarket notification
status, if appropriate
– Regulations establish special controls, when appropriate
– ~1,700 device types covering 16 different medical specialties
15 May 2014
Classification Framework
• 21 CFR 860 – Medical Device Classification Procedures
• 21 CFR 862 – Clinical Chemistry & Clinical Toxicology
• 21 CFR 864 – Hematology & Pathology
• 21 CFR 866 – Immunology & Microbiology
• 21 CFR 868 – Anesthesiology
• 21 CFR 870 – Cardiology
• 21 CFR 872 – Dental
• 21 CFR 874 – Ear, Nose & Throat
• 21 CFR 876 – Gastroenterology-urology
15 May 2014
Classification Framework
• 21 CFR 878 – General & Plastic surgery
• 21 CFR 880 – General Hospital & Personal Use
• 21 CFR 882 – Neurological
• 21 CFR 884 – Obstetrical & Gynecological
• 21 CFR 886 – Ophthalmic
• 21 CFR 888 – Orthopedic
• 21 CFR 890 – Physical Medicine
• 21 CFR 892 – Radiology
15 May 2014
Classification Framework
15 May 2014
Classification Framework
• FDA Product Codes
– No established legislative or regulatory authority
– Define specific device types within a classification regulation
15 May 2014
Exempt from Premarket Notification
• Most Class I devices and some Class II devices are exempt from
premarket notification requirements (i.e., 510(k))
– As established by classification regulations
• “.9 exceptions”
– Each classification regulation includes a general requirement
that a device is exempt from premarket notification regulations
only if there is already a similar device on the market with the
same intended use and fundamental scientific technology
• Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act
– If not, manufacturer must still submit a 510(k) for the device
15 May 2014
Request for Classification – 513(g)
• If there is uncertainty regarding the classification of a medical
device, manufacturers can submit a Request for Classification
under 513(g)
• Subject to user fees ($3,490 for FY2014)
• Contents:
– Cover letter
– Description of the device
– Description of what device is to be used for
– Proposed labeling (yours and similar, legally marketed device)
• Guidance: FDA and Industry Procedures for Section 513(g)
Requests for Information under the Federal Food, Drug, and
Cosmetic Act (2012)
15 May 2014
Premarket Notification – 510(k)
• Comparison to predicate device to determine if they are
substantially equivalent
– 510(k) is “cleared” rather “approved”
• Substantial equivalence:
– Same intended use as predicate device
– Either same technological characteristics as predicate or
different technological characteristics but not raise new
questions of safety or effectiveness
• Predicate device:
– Legally marketed Class I or Class II device
– Class III device for which FDA has not yet required premarket
approval (PMA)
15 May 2014
Premarket Notification – 510(k)
• If FDA determines not substantially equivalent (NSE):
– Resubmit 510(k) with new data
– Request Class I or Class II designation via de novo pathway
– File reclassification petition
– Submit a premarket approval (PMA) application
15 May 2014
Identification of a Predicate Device
• Product Lifecycle database:
– Cleared 510(k)s (or PMAs)
– Adverse events
– Recalls
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Identification of a Predicate Device
• Published 510(k) summaries
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Identification of a Predicate Device
• Competitor marketing materials
15 May 2014
Types of 510(k)s
• FDA Guidance: The New 510(k) Paradigm: Alternate Approaches
to Demonstrating Substantial Equivalence in Premarket
Notifications (1998)
– Types of 510(k)s not defined within law or regulation
User Fee
FDA Review Time Frequency
(# 2014 YTD)
Traditional 510(k)
$5,170
90 days
884
Special 510(k)
$5,170
30 days
188
Abbreviated 510(k)
$5,170
None?
40
15 May 2014
Contents of a Traditional 510(k)
• Cover letter & 510(k) cover sheet (Form FDA 3514)
• Device name, classification & description
• Applicant’s identification & FDA registration number
• Substantial equivalence comparison with predicate device(s)
• Standards (see Form FDA 3654)
• Performance data to demonstrate as safe and effective as predicate
• Labeling
• Class III Certification & Summary, if applicable
• 510(k) summary or statement
• Truthful and Accuracy Statement
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Contents of a Traditional 510(k)
• If applicable:
– Software validation
– Biocompatibility data
– Sterilization and packaging data
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Substantial Equivalence Comparison
Predicate Device
K141234
My Device
Manufacturer
ACME
My Company
Intended Use
Intended to treat male
pattern baldness in men
over 40.
Intended to treat male
pattern baldness in men
over 40.
Classification
Class II
Class II
Product Code
ABC
ABC
Principle of Operation
Manual massage of the
scalp
Electrical stimulation of
dormant follicles
Sterilization
No thanks
No thanks
Materials
Krytonite
Kryptonite
Dimensions
Etc., etc., etc.
15 May 2014
Special 510(k)s
• Modification to manufacturer’s own device
• Not applicable for:
– Changes to intended use or indications for use
– Change to fundamental scientific technology
– FDA can and does convert to traditional
• Focuses on the changes to your device
– Risk management & design control
15 May 2014
Special 510(k)s
• Contents:
– 510(k) coversheet (Form FDA 3514)
– Name & 510(k) number for legally cleared device
– Description of modified device
– Proposed labeling
– Concise summary of design control activities
• Risk analysis
• Verification & Validation activities
• Declaration of Conformity with Design Control requirements
15 May 2014
Abbreviated 510(k)s
• Focus on conformance to an established Special Control
– Product-specific FDA guidance document
– FDA-recognized product standard
• Contents:
– 510(k) coversheet (Form FDA 3514)
– Description of device
– Proposed labeling
– Summary report that shows how standard/guidance applied
• Specifically how risks were addressed
• Justification for deviations from the standard
– Declaration of conformity to the standard
15 May 2014
Refuse to Accept Process
• FDA Guidance: Refuse to Accept Policy for 510(k)s Guidance for
Industry and Food and Drug Administration Staff (2012)
• Within 15 calendar days, FDA will preview submission for inclusion
of appropriate content
– Combination device?
– Submitted to appropriate Center?
– 510(k) eligible?
– Organization?
– Include appropriate elements?
15 May 2014
Standards
15 May 2014
Pre-amendment Devices
• On the market prior to May 28, 1976
• Documentable evidence
– Catalogs/datasheets
– Shipping records/invoices
– Employee affidavit
• Pre-amendment Determination Request – guidance on FDA
website
15 May 2014
Current Developments in 510(k)
• Draft Guidance: The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)] (2011)
• Modifications to 510(k) devices:
– Report to Congress: Report on FDA’s Policy to be Proposed
Regarding Premarket Notification Requirements for
Modifications to Legally Marketed Devices (January 2014)
15 May 2014
510(k) Tips
• More than just gathering engineering and marketing information
– Tell the “story”
• Work with engineering and marketing
– How do you want to market the device?
• Clearly state intended use and indications
• Address differences between your device and predicate
• Implement thorough QC process
– RTA checklist
15 May 2014
Additional Resources
• Guidance for Industry: General/Specific Intended Use, 1998
• K97-1: Deciding When to Submit a 510(k) for a Change to an
Existing Device, 1997
• K95-1: 510(k) Requirements During Firm-Initiated Recalls, 1995
15 May 2014
Exercise
• For the pedicle bone screw, what is the classification?
– Classification
– Regulation
– Product Code
– Identify two applicable predicates
– Identify applicable standards
15 May 2014

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