FDA 510(k) 101 - The Orthopaedics Internet Portal · FDA 510(k) 101. The Basics. Floyd G. Larson....
Transcript of FDA 510(k) 101 - The Orthopaedics Internet Portal · FDA 510(k) 101. The Basics. Floyd G. Larson....
FDA 510(k) 101The Basics
Floyd G. LarsonPresident, PaxMed International
San Diego, CA
OMTEC June 17, 2010
Chicago
Agenda
History of 510(k) processFDA’s risk-based approachFDA guidance and standardsStructure of a 510(k)Submission to FDAFollow-up with FDA
History of 510(k) ProgramBegan May 28, 1976
– Medical device amendments to Federal Food Drug & Cosmetic Act (“the Act”)
Section 510(k) of the ActInitial regulation of medical devices“Grandfathered” devices already on market, if risk low (Class I or II) – Pre-amendments devicesNew devices cleared if “substantially equivalent” to devices on market prior to May 28, 1976
– Now can be “SE” to devices that are “SE”
Section 510(k) of the Act(k) Each person who is required to register under this section and
who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 523(a) (in such form and manner as the Secretary shall by regulation prescribe)(1) the class in which the device is classified under section 513 or if
such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and
(2) action taken by such person to comply with requirements under section 514 [performance standards] or 515 [premarket approval] which are applicable to the device. . . .
Premarket “Notification”
Original 510(k) process involved sending FDA a letter indicating intent to introduce new device into interstate commerce– If no response within 90 days, OK to sell
Soon changed to require that a favorable letter from FDA be received prior to marketingReview process now much more rigorous– “Mini-PMA”
An early 510(k)
Here it is – all 6 pages
The beginning of the content
This is all there is!
How are things different now?510(k)s may have 200-500 pages (or more)Solid predicate device(s) are essentialNeed carefully considered Indications for UseNeed strong supporting data– Performance testing – bench– Performance testing – animal – Performance testing – clinical
A growing number of submissions
Need strong Substantial Equivalence argument
Risk-based Classification
Three Regulatory Classes (level of control based on risk):
Class I – General Controls (most exempt from 510(k))
Class II – General Controls & Special Controls (Guidance Documents, Standards)
Class III – General Controls & Premarket Approval
What is Class III?
FDA has determined that Special Controls are not sufficient to ensure safety and effectivenessClass III devices generally are not eligible for 510(k) clearance (need Premarket Approval)– Exception for Preamendments Class III devices for
which FDA has not yet issued a call for Premarket Approval applications
Devices Exempt from 510(k)Preamendments devicesUnfinished devicesDevices exempt by statute or by regulation– 739 Class I, 74 Class II
Finished devices not sold in U.S. Devices covered under another 510(k)– Private labeled devices
Custom devicesVeterinary devices
Is a 510(k) needed?
Is it a Medical Device?Is it exempt from 510(k) requirement?– Note that it probably is subject to QSR –
21CFR 820Is it a PMA device?
Types of 510(k)sClass II and Preamendments Class III
Traditional– 90-day review
Special– Relies on Design Controls– 30-day review
Abbreviated– Relies on conformance to standards
Special 510(k)Used to obtain clearance for a change to a manufacturers own deviceSame Indication for UseBased on conformance to Design Controls (21CFR 820.30)Submission not easier than TraditionalReview time 30 days
See FDA guidance at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080189.pdf
Abbreviated 510(k)
Based on conformance to standards and/or FDA guidance documentsNo advantage for review timingNot commonly usedStandards are also used in Traditional 510(k)s
Role of Standards
Voluntary– Organizations such as ASTM, ISO– Voting process – ASTM by company or individual, ISO by
country
Recognized by FDA (see FDA recognition list)– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
search.cfm
Even when they are not performance standards, they are useful in aiding comparison to historical data or predicate devices
Substantial EquivalenceA device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; andhas the same technological characteristics as the predicate;
or has the same intended use as the predicate; andhas different technological characteristics and the information submitted to FDA; does not raise new questions of safety and effectiveness; anddemonstrates that the device is at least as safe and effective as the legally marketed device.
510(k) Review Flowchart
510(k) Review Flowchart
Reviewer Template for 510(k)
Reviewer Template for 510(k)
Reviewer Template for 510(k)
Reviewer Template for 510(k)
Reviewer Template for 510(k)
Reviewer Template for 510(k)
What does the 510(k) processaccomplish (and what not)?
Outcome of 510(k) review determines classification of a device
• If Substantially Equivalent (“SE”) takes classification of predicate• If Not Substantially Equivalent (“NSE”), device is Class III
510(k) clearance is not “approval”• That requires the Premarket Approval (PMA) process
A 510(k) is not registration or device listing
Nuts and Bolts
Beginning the SubmissionDefine intended use of deviceSearch for FDA guidance documents– FDA database of guidance documents
Determine classification– FDA database of product codes– Look at product codes of similar devices (510(k) summaries)– Read classification regulation
Search for predicate device candidates– Same intended use and product code– Similar technological characteristics– Multiple predicate devices OK
Collect key components
Key Components
Product list with part numbers for all products to be cleared, including all relevant accessoriesEngineering drawings for all components on product listDevice Description – especially characteristics not obvious from the drawings (e.g., description of surface treatment and process used) Material Certifications or Material Standards acceptable to FDA
Key Components
Labeling - copies or drafts– Instructions for Use (Package Insert) – In English– Product Labels, with text for most symbols– Surgical and/or Prosthetic Manuals– Product Brochures– List of all claims for which clearance is requested
Key Components
Packaging description and drawingsPlanned sterilization method and validation plans –including corresponding accepted FDA standardTesting completed (including protocol or standard to which the protocol is written, and final test reports)
Format of a Traditional 510(k)
FDA Guidance – August 12, 200521 sectionsSome may not applyMaintain numbering and titles
Sections of a 510(k)
Cover PageTable of Contents1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet3. 510(k) Cover Letter4. Indications for Use Statement5. 510(k) Summary or 510(k) Statement6. Truthful and Accurate Statement7. Class III Summary and Certification
Sections of a 510(k)
8. Financial Certification or Disclosure Statement9. Declarations of Conformity and Summary Reports
– Include Standards Data Reports (Form FDA 3654) for each standard referenced in submission
10. Executive Summary11. Device Description12. Substantial Equivalence Discussion13. Proposed Labeling
Sections of a 510(k)
14. Sterilization and Shelf Life15. Biocompatibility16. Software17. Electromagnetic Compatibility and Electrical Safety18. Performance Testing – Bench19. Performance Testing – Animal20. Performance Testing – Clinical21. Other
Steps in Writing a 510(k)
Write Device DescriptionSummarize bench testingSummarize animal testing (if applicable)Summarize clinical study (if applicable)Write text for other sections– Biocompatibility– Sterilization and shelf life (include packaging)
Write Substantial Equivalence section
Steps in Writing a 510(k)Complete administrative sections– FDA User Fee Cover Sheet– CDRH Cover Sheet– 510(k) Cover Letter– Indications for Use Statement– 510(k) Summary or 510(k) Statement– Truthful and Accurate Statement– Class III Summary and Certification (if applicable)– Financial Certification or Disclosure Statement (if applicable)– Declarations of Conformity and Summary Reports– Executive Summary– Certification re clinical trials databank (if applicable)
Submitting the 510(k)Submit TWO paper copies or ONE paper copy and ONE electronic (pdf) copy– If electronic copy is submitted, see for format
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm
Include MS Word file of text for reviewer useRetain an identical file copyUse 8.5 inch x 11 inch paper3-hole punch left marginYour fancy binder will be discarded – (probably used for employee children’s school projects)
Submitting the 510(k)Submit by traceable courier service to:– Food and Drug Administration
Center for Devices and Radiological HealthDocument Mail Center - WO66-G60910903 New Hampshire AvenueSilver Spring, MD 20993-0002
For 510(k)s reviewed by CBER, send to:– FDA/CBER
1401 Rockville PikeHFM-99, Room 200NRockville, MD 20852-1448
What’s Next?Administrative review for completenessFDA acknowledgement letter– Includes assigned “K” number – not a clearance
FDA has 90 calendar days to review a Traditional 510(k) Premarket Notification– Target for questions is 75 days
FDA has 30 days to review a “Special 510(k)”Reviewer may call sponsor or consultant with questions– If questions can be resolved easily, a hold might be avoided
What’s Next?Questions may come by email, FAX or letter (request for additional information – “AI” Letter)– Submission will be placed on hold
Stops FDA 90-day clockStarts sponsor 30-day clockExtensions automatically granted on request, to a total of 180 days
When sponsor submits response to questions, FDA clock starts running againFDA might ask a second round of formal questions– Submission will be placed on hold
Stops FDA 90-day clockStarts sponsor 30-day clockExtensions automatically granted on request, to a total of 180 days
What’s Next?Generally no opportunity for third round of questionsIf all questions answered satisfactorily– “Substantially Equivalent” letter – Clearance to market
If reviewer and FDA management not satisfied– “Not Substantially Equivalent” letter – Device is Class III– Some NSE letters read more like “AI” letters
Invite resubmission as 510(k) with additional informationUsually requires clinical or animal data
Questions?
Key FDA website links
Classification database– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
510(k) database– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Guidance document databasewww.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
Device Advicewww.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
Key FDA Guidance (General)
Format for Abbreviated & Traditional 510(k)s– www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm084396.pdf
Certifications re clinical trials databank– www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm
User Fees and Refunds for 510(k)s– www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm089755.pdf
Bundling Multiple Devices or Multiple Indications in a Single Submission
– www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089732.pdf
To contact us
Floyd Larson or Kevin ThomasPaxMed International, LLC
Office (858) 792-1235
Email [email protected]@paxmed.com
Thank you.