Regulatory Considerations in the
   Development of Medical
          Electronics
        IEEE Medical Devices SIG
        ...
Garth Nobis--Bio
• BIE and MBA (GMI, University of Dayton)
• Automotive and high volume electronics
  – General Motors (su...
Scope of Discussion: Regulatory
Considerations in the Development of
        Medical Electronics
• What consultants need t...
An FDA Basic
• Establish: define, document, and implement

• Doing is important

• Documentation proves the Doing

• “The ...
Medical Device Definition (FDA)
•   Simple to complex devices, including IVD
•   If a product is labeled, promoted or used...
Definitions, Registration and Listing
• Manufacturer - Makes by chemical, physical, biological, or
  other procedures, any...
Manufacturer Obligations
                        (Not a complete list)
• Permission to market a medical device
   – 510(k)...
Electronic Product Radiation
  Control Program (21CFR1000 etc)
• FDA regulates radiation-emitting electronic products (pro...
Design Controls (820.30)
• Apply to Design/Development (not Research)
• Apply to IDE, class II, class III, software
  cont...
Elements of Design Control
• Client and Consultant need to align responsibility for:
   – Planning
   – Design Input (Stan...
Elements of Design Control
                                  (Continued)
   – Design Reviews
   – Design Verification
    ...
Standards and Guidance
• Recognized Consensus Standards
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/se...
Discussion
• Questions?

• Answers?




               Garth Nobis, April 20, 2010, IEEE Medical
                   Device...
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Regulatory Considerations In Medical Electronics G Nobis Apr 20 2010

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Regulatory Considerations in the Development of Medical Electronics, presented April 20, 2010 at IEEE Medical Devices SIG, Santa Clara, CA

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Regulatory Considerations In Medical Electronics G Nobis Apr 20 2010

  1. 1. Regulatory Considerations in the Development of Medical Electronics IEEE Medical Devices SIG April 20, 2010 Garth Nobis gnobis1@gmail.com 408 313 7882 www.garthnobis.com
  2. 2. Garth Nobis--Bio • BIE and MBA (GMI, University of Dayton) • Automotive and high volume electronics – General Motors (suspension and motors) – Motorola (Ford Engine Control modules) • Medical Device Regulatory and Quality Becton Dickinson Guidant Vascular Accuray (CyberKnife) Oraya (radiation, eyes) Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  3. 3. Scope of Discussion: Regulatory Considerations in the Development of Medical Electronics • What consultants need to consider: - Understand your client’s responsibilities to FDA et al - Your responsibility to client - Liability - What is in your contract? Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  4. 4. An FDA Basic • Establish: define, document, and implement • Doing is important • Documentation proves the Doing • “The faintest pencil lead … “ Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  5. 5. Medical Device Definition (FDA) • Simple to complex devices, including IVD • If a product is labeled, promoted or used in a manner that meets the definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act ... A device is: • "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 US Pharmacopoeia… – 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.“ Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  6. 6. Definitions, Registration and Listing • Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act. (R and L required) • Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer. (R & L req’d) • Specification Consultant - (Register and List NOT required) Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  7. 7. Manufacturer Obligations (Not a complete list) • Permission to market a medical device – 510(k) clearance or PMA approval • IDE approval needed if clinical data required • Quality System Regulation (GMP) 21CFR820 – Design and development, risk reduction – Documentation – Supplier Controls – Management processes – Production, acceptance, release processes – Distribution, Complaints, MDRs, recalls – EU: ISO 13485/2003 is similar • Also, Electronic Products Radiation Control Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  8. 8. Electronic Product Radiation Control Program (21CFR1000 etc) • FDA regulates radiation-emitting electronic products (protect the public from hazardous and unnecessary exposure to radiation from electronic products). • Apply to any "electronic product" which is defined as any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation • (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation. Examples of electronic products: • Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices • Non-medical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  9. 9. Design Controls (820.30) • Apply to Design/Development (not Research) • Apply to IDE, class II, class III, software contained, and (5) class I devices • Additional requirements: – Risk Management (ISO 14971/2007) – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  10. 10. Elements of Design Control • Client and Consultant need to align responsibility for: – Planning – Design Input (Standards, Guidances, US/OUS) • design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. • approval, including the date and signature of the individual(s) approving the requirements, shall be documented – Design Output • design output in terms that allow an adequate evaluation of conformance to design input requirements • acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified • Design output shall be documented, reviewed, and approved before release Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  11. 11. Elements of Design Control (Continued) – Design Reviews – Design Verification • Design verification shall confirm that the design output meets the design input requirements – Design Validation • shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. – Design Transfer – Design Changes – Design History File • How will this information be included in IDE, 510(k), or PMA? (or CE Technical File?) Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  12. 12. Standards and Guidance • Recognized Consensus Standards http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/se arch.cfm • FDA Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationan dGuidance/GuidanceDocuments/default.htm • European Harmonized Standards http://ec.europa.eu/enterprise/policies/europea n-standards/documents/harmonised-standards- legislation/list-references Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com
  13. 13. Discussion • Questions? • Answers? Garth Nobis, April 20, 2010, IEEE Medical Devices SIG, gnobis1@gmail.com

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