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Premarket Notification [510(k)] Procedures Rod Perez, M.S.E. Consumer Safety Officer

Premarket Notification [510(k)] Procedures Rod Perez, M.S.E. Consumer Safety Officer Division of Small Manufacturers, International and Consumer Assistance Western Canada 2009. Medical Device Amendments. Signed into law on May 28, 1976 Gave FDA authority to regulate medical devices

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Premarket Notification [510(k)] Procedures Rod Perez, M.S.E. Consumer Safety Officer

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  1. Premarket Notification [510(k)] Procedures Rod Perez, M.S.E. Consumer Safety Officer Division of Small Manufacturers, International and Consumer Assistance Western Canada 2009

  2. Medical Device Amendments • Signed into law on May 28, 1976 • Gave FDA authority to regulate medical devices • Defined a device [Sec. 201(h) of the Act] • Required classification of device types legally on the market at that time • Led to classification of approximately 1,700 different generic types of devices and grouped them into 19 medical specialties • Required premarket review of devices

  3. What Is a Medical Device? • an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes

  4. Pre-Amendments vs. Post-Amendments • The FFD&C Act divided the arena of medical devices depending on when the devices were introduced into commercial distribution: • Pre-Amendments Devices (pre-May 28, 1976) • Exempted (with conditions) from marketing clearance • Post-Amendments Devices (post-May 28, 1976) • Requires marketing clearance

  5. Classification • Classification regulations for individual device types are found in 21 CFR Parts 862-892 • Regulations describe the device type as it existed prior to May 28, 1976 • New indications for use or new technologies are assigned new product codes

  6. What Is a Device Type? • 21 CFR 860.3(i) – Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness

  7. Regulatory Class • Class determines type of premarket submission required by FDA • Class I or II 510(k) Exempt • Subject to limitations on exemptions covered under 21 CFR xxx.9 (e.g., 862.9 to 892.9) • • Class I or II Non-510(k) Exempt • 510(k) Required • Class III • PMA [510(k) for pre-Amendments devices until 515(b) calls for PMA or the device type is reclassified]

  8. Class I Exemptions • Section 510(l) of the FD&C Act • All Class I Devices are Exempt except: • those intended for a use which is of substantial importance in preventing impairment of human health, or • those that present a potential for unreasonable risk of illness of injury

  9. Class II Exemptions • Section 510(m) of the FD&C Act • Class II devices that do not require 510(k)s to provide reasonable assurance of safety and effectiveness • 75 device classifications exempt* • Final Rule November 3, 1998 * Subject to the Limitations on Exemptions

  10. Limitations of Exemption from 510(k) - Class I and II Found in “.9” of Classification Chapters • Four Limitations: • If the device has an intended use that is different from the intended use of a legally marketed device in that generic type • If the device operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type

  11. Limitations of Exemption from 510(k) - Class I and II Found in “.9” of Classification Chapters • Four Limitations: • There are specific limitations for in vitro diagnostic devices • There are device-specific limitations as specified in a classification regulation

  12. Intended Use vs.Indication for Use - No real clear FDA definition - Intended use usually provides broad, general use of the device and intent of the user - Indications for use may refer to specific population of the device use (adult vs. pediatric) - Both intended use and indications for use can be broad (surgical laser used for general surgical procedures) - Example of indication for use claim would be: for surgical removal of kidney-stones from kidney.

  13. What Is a 510(k)? • Premarket Notification • Section 510(k) of FD&C Act • 21 CFR 807 Subpart E • Marketing clearance application • Allows FDA to determine substantial equivalence (SE) relative to a legally marketed medical device

  14. What Is Not a 510(k)? • A form • Establishment Registration • Device Listing • Premarket Approval (PMA)

  15. 510(k) & Classification • A 510(k) is the classification process for individual post-amendments devices by: • Finding the device substantially equivalent (SE), OR • Finding the device not substantially equivalent (NSE)

  16. When Is a 510(k) Required? • When introducing a device to the U.S. market for the first time • When changing the indications for use for a marketed device • When making significant modifications to a previously cleared device

  17. 510(k) Exempt Devices • Unfinished Devices (Components) • Class I (739) and Class II (74) devices exempt by statute or regulation • Finished devices not sold in U.S. (Export-Only) • Devices covered under another 510(k) • For Private Label Distribution • Pre-amendments devices • Custom Devices • Veterinary Devices

  18. Who Must Submit a 510(k)? • Manufacturers • Specifications Developers • Repackagers who modify the device or its labeling • Relabelers who modify the labeling (e.g., instructions for use) • Anyone who both manufactures and distributes

  19. Who Is Not Required to Submit a 510(k)? • Private Label Distributor who only adds company name and wording such as: • “Distributed by ___________” or • “Manufactured for _________” • Repackager who does not alter the product labeling • Distributor or U.S. Importer who furthers marketing of the device, but does not alter labeling or device specifications

  20. What Is a Predicate? • 21 CFR Part 807.92(a)(3) - An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process

  21. What Is a Predicate Device? A legally marketed device that does not require Premarket Approval (PMA) Examples include: A Pre-Amendments device A device found Substantially Equivalent (SE) by the FDA A reclassified device

  22. Substantial Equivalence (SE) • A device is “substantially equivalent” when compared to a legally marketed or predicate device if it: • has the same intended use • has the same technological characteristics • has different technological characteristics which do not raise new questions of safety and effectiveness • can be demonstrated to be as reasonably safe and effective as the predicate device

  23. Substantial Equivalence • Substantial Equivalence must be established relative to a legally marketed or predicate* device that does not require a PMA • Acceptable “predicate types” include: • A Pre-amendments device* • A device found by FDA to be Substantially Equivalent (SE), or • A reclassified device* *21 CFR 807.92(a)(3)

  24. Substantial Equivalence • SE comparison should account for: • intended use and indications for use • target population • anatomical sites • where used (hospital, home, ambulance, etc) • energy used and/or delivered • human factors • design • performance data (engineering, bench, animal, design verification, human factors, clinical)

  25. Substantial Equivalence • standards • materials • biocompatibility • compatibility with the environment and other devices • sterility • electrical safety • mechanical safety • chemical safety • thermal safety • radiation safety

  26. Not Substantially Equivalent (NSE) • There is no predicate device • Device has new intended use • Device has different technological characteristics compared to the predicate device and raises new types of safety and effectiveness questions

  27. 510(k) Decisions • If found NSE: • Device automatically classified as Class III • There are other mechanisms that may be explored for U.S. marketing • Reclassification, PMA, HDE, De Novo • If found SE: • Firm may proceed to market

  28. Reclassification • Changes in classification are based on FDA's receipt of new information about a device • FDA may, on its own, or in response to an outside petition, change a device's classification by regulation • A manufacturer who wishes to have a device reclassified to a lower class must convince FDA that the less stringent class requirements will be sufficient to provide reasonable assurance of safety and effectiveness

  29. Reclassification • FDA notifies petitioners of determinations made on petitions for reclassification by a reclassification letter.  • If a determination is made to reclassify a device, FDA publishes a proposed rule to reclassify in the Federal Register which includes the scientific justification for reclassification • A final rule is published in the Federal Register which changes the reclassification

  30. De Novo Process • FDAMA amended Section 513(f)(2) to provide a new mechanism for classifying new Class III devices for which there is no identifiable predicate device • Provides a possible route to market low risk device types • It allows the recipient of an NSE (not substantially equivalent) letter to request a risk-based classification determination to be made for the device • Does not apply to devices that have been classified by regulation into class III • An applicant of a 510(k) who receives an NSE determination can request a De Novo classification of the product into Class I or II

  31. De Novo Process • The request must be in writing and sent within 30 days from the receipt of the NSE determination • The request should include: • device description, labeling, reasons for the recommended classification (into Class I or II), and information to support the recommendation • There is a 60-day FDA review period • If FDA classifies the device into Class I or II, the applicant will then receive an approval order to market the device • If FDA determines that the device will remain in the Class III category, the device cannot be marketed until the applicant has obtained an approved PMA

  32. Finished Device • 820.3(l) [QSR] - Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized • Finished device is subject to 510(k) requirements if it is both in final form and for sale to an end user

  33. Accessories and Components • Component (820.3(c)) - Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device • Accessories - ”extras” (not defined in the regulations) • Accessories/components to a device take on the same classification as the "parent" device unless they are separately classified • A finished accessory or a finished component sold to an end user is subject to 510(k) requirements

  34. Convenience Kits • Two or more separate types of finished devices packaged together for the convenience of the user is considered to be a kit • The classification of the kit is based on the highest classification of the devices that are provided in the kit • Submissions for convenience kits should identify all devices provided in the kit and document the marketing status of each device

  35. Convenience Kits • If a 510(k) submission is required, a kit certification should be included. If a 510(k) is not required, this information should be maintained in Device Master Record • Certain convenience kits that meet the criteria in the Convenience Kit Interim Regulatory Guidance are under enforcement discretion and do not require a 510(k)

  36. Combination Products • A combination product is a product comprised of two or more regulated components (drug/device or biologic/device) that are combined as a single entity or labeled for use with a specified drug, device, or biologic where both are required to achieve the intended use, indication, or effect • FDA has developed InterCenter agreements which establish the lead FDA Center for review and oversight of combination products • The Office of Combination Products (OCP) assigns review responsibility for combination products • OCP is also responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional designation

  37. In Vitro Diagnostic Devices • In vitro diagnostics are defined as medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease • Devices are subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 • CLIA requirements vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results • Three categories of testing based on the complexity of the testing methodology: • waived tests • tests of moderate complexity, and • tests of high complexity

  38. In Vitro Diagnostic Devices • Laboratories performing moderate- or high-complexity testing or both must meet requirements for proficiency testing, patient test management, quality control, quality assurance, and personnel. These specific requirements do not apply to tests in the waived category • May use CeSub eSubmitter software to submit single or bundled 510(k) submissions/supplements and CLIA waiver and categorization applications • In vitro diagnostic products have special labeling requirements and distribution restrictions under 21CFR 809, In Vitro Diagnostic Products for Human Use

  39. 510(k) Content and Format Code of Federal Regulations (CFR) 21 CFR 807.87 – Content 21 CFR 807.90 – Format Device-Specific Guidances http://www.fda.gov/cdrh/guidance.html CFR on the Internet at: http://www.fda.gov/cdrh/devadvice/365.html Device Advice

  40. 510(k) Content • Submitter’s name, address, phone/fax #, contact person, rep./consultant name, establishment registration number • Device Classification Name, CFR number, device class, ProCode • Common/usual name and trade/proprietary name and model numbers • Copy of Medical Device User Fee Cover Sheet • CDRH Premarket Review Submission Cover Sheet

  41. 510(k) Content • Identification of legally marketed device(s) to which substantial equivalence is claimed • Compliance with section 514 Special Controls • Indications for Use Statement • Truthful and Accurate Statement • Standards Data Report, FDA Form 3654 (if applicable) • If 510(k) has clinical trial - FDA Form 3674

  42. 510(k) Content • Photographs, engineering drawings • Substantially equivalent statement and detailed comparison with predicate device • Statement of similarities and/or differences with predicate device • Supporting data for device modifications • 510(k) Summary or 510(k) Statement per 21 CFR 807.92 & 807.93

  43. 510(k) Content • Proposed labeling (package inserts, service manuals, instructions for use, advertising and/or promotional materials) • Adherence to voluntary standards • Financial Certification or Disclosure Statement or both

  44. 510(k) Content • Performance Data (bench, animal, clinical) • Photographs, Engineering Drawings • Biocompatibility, Toxicology, Sterilization and Shelf Life data (as applicable) • Electromagnetic Compatibility and Electrical Safety data (as applicable) • Software/Hardware Information (as applicable) • Device-specific requirements per available guidance documents

  45. 510(k) Content • Class III 510(k)s must include: • Certification that search of scientific literature has been conducted, and • Summary of available adverse S&E data with all specific citations from the scientific literature

  46. Clinical Data Requirements • 10-15% of all 510(k)s require some clinical data • May be required when intended use or technology or materials differ from the predicate device • Must be collected under the Investigational Device Exemptions (IDE) regulations (21 CFR Part 812)

  47. Request for Additional Information • For administratively incomplete submissions (Refuse to Accept) • When additional regulatory information or performance data is required to demonstrate substantial equivalence

  48. Request for Additional Information • Reviewer request made via telephone or letter • Additional information should be sent to the Document Mail Center within 30 days. • Submitter may request extension of up to 180 days

  49. FDA Review Procedure • Application Log-in • Division Acceptance • Assignment to Reviewer/Review Group • ODE Review • Decision Letter Issued By Reviewing Division • SE Decision Made Public Within 30 days

  50. Expedited Review • Expedited review of devices subject to 510(k) will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives (preventative, diagnostic, or therapeutic) or when the new medical device promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities.

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