Medical Device Pathways to Market and Software Requirements
Tammy B. Carrea, BS, CQA, RAC – July 12, 2006
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Medical Devices
Pathways to Market and Device Classification
Pathways to Market No Pre-Approval – exempt from 510(k) 510(k) PMA de novo – risk based approval HDE – Humanitarian Device Exemption Pathway to Clinical Trials IDE, Investigational Device Exemption Device Classification Class I – general controls Class II – general and special controls Class III – cannot assure safety/effectiveness through controls. NSE devices requiring a PMA. Generally life supporting or sustaining, high risk devices.
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Software Guidance Documents for FDA Submissions
Human Factors Points to Consider for IDE Devices (user operation oriented design) and Do It By Design Off-The-Shelf Software Use in Medical Devices (risk based analysis) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (risk based Level of Concern) IEC 60601-1-4 Medical Electrical Equipment – Part 1-4: General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems and ISO/IEC 12207 Information Technology – Software Life Cycle Processes (Recognized Consensus Standards)
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Investigational Device Exemptions Planning
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Significant vs. Non-Significant Risk Software requirements for IDEs are the same as those for other pre-market submissions – expect to meet design control requirement and software development requirements Pre-IDE IDE meetings – Early Collaboration Post IDE Changes Supplements 5 day letters Annual Reports
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510(k)s – 21 CFR Part 807
Comparison submission to demonstrate that the new device is as safe and effective as another similar device Substantially equivalent to a predicate – same intended use and technological characteristics Intended use is first hurdle to sub equiv Technological differences second hurdle Safety and efficacy data (including software testing) is required, labeling, device description, etc for a SE comparison Most Class I devices exempt, some Class II devices exempt, and a few Class III devices may be cleared via 510(k) rather than PMA Must be submitted at least 90 days prior to planned commercial interstate distribution Analogous to generic drug applications
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When to Submit a 510(k)?
New device with same intended use as another legally marketed device introduced into commercial distribution New intended use for legally marketed device Significant modification to a currently legally marketed device Reprocessed SUD, Single Use Device
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Types of 510(k)s
Traditional 510(k)
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510(k) Paradigm (1997 FDAMA)
Special 510(k) – design change to device, predicate is original device, relies on design controls i.e. declaration of conformity. Generally reviewed within 30 days. Abbreviated 510(k) – reliance on declarations of conformity to guidances, special controls, and consensus standards in lieu of supporting data.
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510(k) Actions
AI – Additional Information requested by FDA Exempt or 510(k) not required, device not regulated SE – Substantially Equivalent. Represents clearance to market, not FDA approval. NSE – Not substantially equivalent based on performance data File a new 510(k) NSE – Not substantially equivalent based on intended use or predicate device Automatic Class III requiring a PMA or, Petition to down classify Sponsor can w/draw 510(k) prior to actions
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If Device is Found NSE,
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File a new 510(k) with new data Not enough data to make a determination of SE File a Reclassification Petition New intended use Inappropriate predicate File a PMA Class III determination
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513(f)(2) - Evaluation of Automatic Class III Designation (FDAMA)
De Novo process
If found NSE, Sponsor - 30 days to file a request for risk based classification.
FDA has 60 days to review and issue a written order.
If found to be Class I or II, FDA will publish within 30 days a new classification in the Federal Register.
If found to be Class III, sponsor must file a PMA.
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Examples Verichip Implantable Radiofrequency Transponder Given Imaging Wireless Gastrointestinal Imaging System 10
When a Change is Made To a Device, Is a New 510(k) Required?
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Change criteria indications for use – always new 510(k) labeling technology, engineering, and performance changes (software) materials changes materials changes to IVDs
Reference the FDA industry guidance document Common error – revision is to be compared to original 510(k) device
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In Vitro Diagnostic Device 510(k)s (OIVD)
Same 510(k) regulations
CLIA complexity rulings
Special labeling requirements OTC (over the counter) ASR (analyte specific reagents) Outer container Package insert and outer packaging
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Biologics 510(k)s
Reviewed by CBER although medical device regulations apply i.e. IDE, 510(k), and PMA Examples of Devices reviewed by CBER Warmer, blood, electromagnetic radiation – Class III Warmer, blood, non-electromagnetic radiation – Class II Blood specimen collection devices-vacuum – Class II Red cell lysing reagent (including elution reagents) – Class I Blood mixing and weighing devices – Class I
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Pre-Market Applications – PMA, 21 CFR Part 814
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Types of PMAs Traditional Modular Streamlined (Pilot) - IVD Product Development Protocol (Pilot)
Humanitarian Device Exemptions
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FDA Actions on PMA
Refuse to File Approvable Non Approvable
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Device Examples
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Class III PMA Devices
replacement heart valves silicone gel-filled breast implants implanted cerebella stimulators
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Class III 510(k) Devices
implantable pacemaker pulse generators endosseous implants
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Class II 510(k) Devices
radiation dosimeter - radiology
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Class II 510(k) Exempt Devices
biofeedback chair - neurology
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Class I 510(k) Exempt Devices
pacemaker polymeric mesh bag – cardiovascular creatine test system - clinical chemistry
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