TITLE:
“ESTAR FOR THE 510K “CLUELESS”
US FDA NEW 510K PREMARKET SUBMISSION TEMPLATE –
AN INTRODUCTION FOR NON-INVITRO MEDICAL DEVICES 510KS
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• MARCH 18th-2021
I.
AGENDA
US FDA Medical Device 101 in a Nutshell
□ Medical devices defined-Definition of 510k – Legal Statute purpose
□ Classes (I,II or III) , Product Classification code, intended use, safety and
efficacy, indications, substantial equivalence for Class II to existing device
(predicate device)
II. 510k Premarket Notification Review Process
□ RTA – US FDA Reviewer’s Refuse to Accept , Some Stats
□ Substantial Equivalence Flowchart
□ Section List of Comprehensive Traditional 510k Submission
III. A new star is born…eStar – defined, sample
screens, garbage-in/garbage-out ….still holds
□ Benefits & Limitation of 510 construction with eStar
□ US FDA on eStar-Deployment, caveats etc.
IV. Q & A
FDASmart - US FDA (“smart”) Consultants
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• NDC Labeler Code (OTC) plus
• OTC Product Listings US FDA;
• Covid-19 PPEs-Hand Sanitizer-US FDA EUA (Emergency Use
Authorization for Covid-19)
• 510ks for Medical Devices Class II, UDI, GUDID
• MedWatch/MAUDE Adverse Event Reporting
• US FDA XML/SPL Specialists
• MICROSOFT PARTNER /GxP Sharepoint (Office 365 Cloud)
Medical Device definition by US FDA:
To determine if your product meets the definition of
a medical device, you should define the intended
use and indications for use of your product.
Once you have defined the intended use and
indications for use of your product, you can
determine if the product meets the definition
of a medical device.
Medical Device Amendments and Device Classification
The Medical Device Amendments (MDA) (Pub. L. 94-295) to the
Federal Food, Drug, and Cosmetic(FD&C) Act were enacted on
May 28, 1976. The MDA directed FDA to issue regulations that
classify all devices that were in commercial distribution at that
time into one of three regulatory control categories: Class I, II, or
III.
•
Class I: Devices are subject to a comprehensive set of regulatory authorities called general
controls that are applicable to all classes of devices.
Examples:
• Electric Toothbrush
•Tongue Depressor
• Bandages
•
•
Class II: Devices for which general controls, by themselves, are insufficient to provide
reasonable assurance of the safety and effectiveness of the device, and for which there is
sufficient information to establish special controls to provide such assurance
Examples:
Catheters
Blood Pressure Cuffs
Syringes
•
Class III: Devices for which general controls, by themselves, are insufficient and for
which here is insufficient information to establish special controls to provide reasonable
assuranceof the safety and effectiveness of the device. Class III devices typically require
premarket approval.
Examples:
Defibrillators
High-frequency ventilators
Cochlear implants
Essence of 510k ?
● 510k Premarket notification is the process by which a new device , i.e., a
post-amendments device, is classified into one of these three device classes
● Required at least 90 days prior to LEGALLY MARkETING in the USA
● US FDA’s mechanism by which FDA could establish reasonable assurance
of safety and effectiveness.
● Medical device submitter submits 510k, US FDA review for RTA (15 days)
then Substantive Review ( 90 days return days)
● Medical devices are classified according to the level of regulatory control
necessary to provide a reasonable assurance of safety and effectiveness
510k IMPERATIVE CONTENTS
• Must-have information for 510k to proceed:
• Classification of your device
• Predicate device(s)
• Final draft labeling
• Specifications including engineering drawings,
photos, etc.
• Performance data such as bench, animal, or clinical
testing (if applicable)
• Sterilization information (if applicable)
• Guidance document(s) specific to your device type,
if it exists
Sections to include in a Traditional or Abbreviated 510(k) and Related Information
Section
Title
Related Information
1
Medical Device User Fee
Medical Device User Fee Cover Sheet
Amendments (MDUFA) CoverSheet
2
CDRH Premarket Review
Submission Cover Sheet
CDRH Premarket Review Submission CoverSheet
3
510(k) Cover Letter
Appendix A of this guidance
4
Indications for Use Statement
Indications for Use (FDA Form 3881)
5
510(k) Summary or 510(k)
Statement
Device Advice “Content of a 510(k)” Section E
6
Truthful and Accuracy
Statement
Device Advice “Content of a 510(k)” Section G43
7
Class III Summary and
Certification
Class III Summary and Certification format
Section
Title
Related Information
8
Financial Certification or
Disclosure Statement
Certification: Financial Interests and
Arrangements of Clinical Investigators(Form
FDA 3454)
Disclosure: Financial Interests and
Arrangements of Clinical Investigators(Form
FDA 3455)
“Financial Disclosure by Clinical
Investigators”
9
Declarations of Conformity and
Summary Reports
“Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for
Medical Devices” Standards and Conformity
AssessmentProgram website
10
Device Description
Section (10) of this guidance
11
Executive Summary/Predicate
Comparison
Section (11) of this guidance
12
Substantial Equivalence
Discussion
“The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]”
13
Proposed Labeling
Device Advice “Contentof a 510k) Section H
Section
Title
Related Information
14
Sterilization and Shelf Life
“Submission and Review of Sterility Information in
Premarket Notification (510(k)) Submissions for
Devices Labeled as Sterile”
For reuse of single use devices, see “Medical Device
User Fee and Modernization Act of 2002 Validation
Data in Premarket Notification Submissions (510(k)s)
for Reprocessed Single- Use Medical Devices.
15
Biocompatibility
“Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management process"”
16
Software
“Guidance for the Content of Premarket Submissions
for Software Contained in Medical Devices”
17
Electromagnetic Compatibility and “Information to Support a Claim of Electromagnetic
Electrical Safety
Compatibility (EMC) of Electrically-Powered Medical
Devices”
See also the FDA-recognized version of ANSI/AAMI
ES 60601-1: Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance or an equivalent method.
18
Performance Testing - Bench
See Section (18) of this guidance
SectionP Title
Related Information
19
Performance Testing - Animal
See Section (19) of this Guidance
20
Performance Testing –
Clinical
See Section 20 in Chapter II(20) of this guidance.
Certification Form: Financial Interests and
Arrangements of Clinical Investigators
Disclosure Form: Financial Interests and
Arrangements of Clinical Investigators
eSTAR Pilot Program
Electronic Submission Template And Resource (eSTAR) is
** Use of eStar Does Not
change 510k STATUTORY
REQUIREMENTS ! +*
►PDF electronic submission template , Pilot February 27-2020
► Will guide premarket notification (510(k)) submitters through the
process of preparing a comprehensive medical device 510(k)
submission.
● Features of eStar to CONSTRUCT 510k SUBMISSION
● Automation (e.g., interactive form construction, autofilling);
● Content and structure that is complementary to (CDRH)
US FDA internal reviewer templates
● Integration of multiple resources (e.g., guidances, databases)
● Guided construction for each submission section
● Automatic verification
Download Non-In Vitro Diagnostic eSTAR PDF
A Star is born …eStar by the US FDA
This Photo by Unknown Author is licensed under CC BY
US FDA 21 CFR Part 211 (cGMPs)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs
/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1
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Find 21 CFR Part 211 where container* OR
closure* AND laborat
Find container* OR closure* AND laborat*
Search then from search results-Create task/subtasks on
Sharepoint – start /end dates, assign to, % completion,
Gantt or Calendar Views
• After you complete your eSTAR file correctly, the status message at the
top will indicate "eSTAR Complete."
• If you submit your eSTAR file while the status message still indicates
"eSTAR Incomplete," your eSTAR file will be excluded from the pilot and
instead processed as an eCopy file.
• Because eSTAR files are by default not eCopy compliant, eCopy
validation will likely fail, and your submission will be placed on hold until
a valid eSTAR file or eCopy file is received.
• Please be advised that the benefits of eSTAR (e.g., no RTA review) are
dependent on accurate responses and FDA will verify the accuracy of
your responses.
• Inaccurate responses, such as inaccurate responses to drop down fields
enabling submitters to omit subsequent questions, may lead to an early
hold in the review of your submission.