The document discusses regulatory considerations for the development of medical electronics. It summarizes Garth Nobis' background working in automotive, high volume electronics, and medical devices. It outlines what consultants need to consider regarding their client's and their own responsibilities to the FDA and regarding liability. It provides definitions of medical devices and manufacturer obligations including obtaining permission to market, following quality system regulations, and implementing design controls.
The regulation of software: Medicines, biologicals, blood, tissues and devices
Regulatory Considerations In Medical Electronics G Nobis Apr 20 2010
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
