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FDA Medical Device Enforcement and Quality System Update

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FDA Medical Device Enforcement and Quality System Update Kimberly Trautman FDA s Medical Device Quality Systems Expert Office of Compliance, CDRH – PowerPoint PPT presentation

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Title: FDA Medical Device Enforcement and Quality System Update


1
FDA Medical Device Enforcement and Quality System
Update
  • Kimberly Trautman
  • FDAs Medical Device Quality Systems Expert
  • Office of Compliance, CDRH

2
FDA Enforcement Update
  • Remarks by
  • Margaret Hamburg, M.D.Commissioner of Food and
    Drugs
  • "Effective Enforcement and Benefits to Public
    Health August 6, 2009
  • FDA must be vigilant, strategic, quick and visible

3
FDA Enforcement Update
  • Post Inspection deadlines 15 day Warning Letter
    Response deadline
  • Decrease time between the inspection and issuance
    of a Warning Letter
  • Increase collaboration with regulatory partners
    such as local, state and international partners

4
FDA Enforcement Update
  • Prioritize enforcement follow-up
  • Act swiftly and aggressively to protect the
    public health
  • Warning Letter Close Out process

5
QS Regulation Cites by Subsystem
PPC CAPA MGMT DC DOC
820.50 820.120 820.60 820.130 820.70 820.140 820.72 820.150 820.75 820.160 820.80 820.170 820.86 820.200 820.250 820.90 820.100 820.198 820.5 820.20 820.22 820.25 820.30 820.40 820.180 820.181 820.184 820.186
6
Warning Letter Cites by QS Subsystem - 2008
  • PPC 241
  • CAPA 237
  • DESIGN 155
  • MGMT 130
  • DOC 82
  • ---------------------------------
  • Total 845

7
Warning Letter Cites by QS Subsystem - 2008
8
Top Ten Warning Letter Cites - 2008
  • 21 CFR 820.22 41
  • 21 CFR 820.30(g) 28
  • 21 CFR 820.198(a) 28
  • 21 CFR 820.75(a) 27
  • 21 CFR 820.100(a) 25
  • 21 CFR 820.30(i) 21
  • 21 CFR 820.184 21
  • 21 CFR 820.30(a) 20
  • 21 CFR 820.80(d) 19
  • 21 CFR 820.198(c) 19

9
Warning Letters with CAPA Subsystem Cites 2008
  • January December 2008
  • FDA issued 98 Warning Letters to medical device
    firms for QS/GMP deficiencies
  • 86/98 or 88 contained cites for CAPA system
    deficiencies

10
Warning Letters CAPA Subsystem Data
Year WLs w/ CAPA cite
2008 98 86 88
2007 74 62 84
2006 79 69 87
2005 97 85 88
2004 113 89 79
2003 69 61 88
11
Warning Letters with PPC Subsystem Cites 2008
  • January December 2008
  • FDA issued 98 Warning Letters to medical device
    firms for QS/GMP deficiencies
  • 80/98 or 82 contained cites for PPC subsystem
    deficiencies

12
Warning Letters with Design Control Cites 2008
  • January December 2008
  • FDA issued 98 Warning Letters to medical device
    firms for QS/GMP deficiencies
  • 54/98 or 55 contained cites for Design Control
    deficiencies

13
Warning Letters Design Control Subsystem Data
Year WLs w/ DC cite
2008 98 54 55
2007 74 42 57
2006 79 47 60
2005 97 49 51
2004 113 57 50
2003 69 39 57
14
Quality System Hot Topics
  • Supplier Controls
  • Corrective and Preventive Actions

15
What is unique about medical devices?
  • Medical Devices utilize a wide range of supplied
    products and services
  • Supplied products
  • Finished medical devices or accessories in the
    case of kits or device systems
  • Electronic parts to include anything from
    individual resistors, capacitors, etc. to
    completed hybrid boards

16
What is unique about medical devices?
  • Supplied products
  • Raw materials such as chemicals, polymers,
    metals, etc.
  • Software packages
  • Antibodies, antigens, etc. for in-vitro
    diagnostic products
  • Finished drugs or APIs in the case of combination
    products

17
What is unique about medical devices?
  • Supplied services
  • Contract manufacturers
  • Contract laboratories
  • Contract sterilizers
  • Calibration test houses
  • Contract installers and service providers
  • Auditors
  • Consultants

18
What is unique about medical devices?
  • Further the supplied products and services cover
    the entire range from a risk perspective.
  • Same supplied product or service for one
    manufacturer may not have the same risks
    depending upon multiple factors.

19
What is unique about medical devices?
  • Same supplier for one product or service may have
    different risks for a different supplied product
    or service.
  • Be wary of utilization of supplier audits without
    understanding the scope of the previous supplier
    audit.

20
Quality System (QS) Regulation21 CFR 820.50
Purchasing Controls
  • Each manufacturer shall establish and maintain
    procedures to ensure that all purchased or
    otherwise received product and services conform
    to specified requirements.

21
Quality System (QS) Regulation21 CFR 820.50(a)
  • (a) Evaluation of suppliers, contractors, and
    consultants. Each manufacturer shall establish
    and maintain the requirements, including quality
    requirements, that must be met by suppliers,
    contractors, and consultants. Each manufacturer
    shall

22
21 CFR 820.50(a) Purchasing Controls
  • (1) Evaluate and select potential suppliers,
    contractors, and consultants on the basis of
    their ability to meet specified requirements,
    including quality requirements. The evaluation
    shall be documented.

23
21 CFR 820.50(a) Purchasing Controls
  • (2) Define the type and extent of control to be
    exercised over the product, services, suppliers,
    contractors, and consultants, based on the
    evaluation results.
  • (3) Establish and maintain records of acceptable
    suppliers, contractors, and consultants.

24
21 CFR 820.50(b) Purchasing Data
  • (b) Purchasing data. Each manufacturer shall
    establish and maintain data that clearly describe
    or reference the specified requirements,
    including quality requirements, for purchased
  • or otherwise received product and services.

25
21 CFR 820.50(b) Purchasing Data
  • Purchasing documents shall include, where
    possible, an agreement that the suppliers,
    contractors, and consultants agree to notify the
    manufacturer of changes in the product or service
    so that manufacturers may determine whether the
    changes may affect the quality of a finished
    device. Purchasing data shall be approved in
    accordance with Sec. 820.40.

26
Preamble to the 1996 QS RegulationComment 99
  • Since FDA is not regulating component suppliers,
    FDA believes that the explicit addition to CGMP
    requirements of the purchasing controls of ISO
    90011994 is necessary

27
Preamble to the 1996 QS RegulationComment 99
  • To ensure purchased or otherwise received product
    or services conform to specifications, purchasing
    must be carried out under adequate controls,
    including the assessment and selection of
    suppliers, contractors, and consultants,

28
Preamble to the 1996 QS RegulationComment 99
  • the clear and unambiguous specification of
    requirements, and the performance of suitable
    acceptance activities. Each manufacturer must
    establish an appropriate mix of assessment and
    receiving acceptance to ensure products and
    services are acceptable for their intended uses.
    ..

29
Preamble to the 1996 QS RegulationComment 99
  • FDA generally believes that an appropriate mix of
    supplier and manufacturer quality controls are
    necessary. However, finished device manufacturers
    who conduct product quality control solely
    in-house must also assess the capability of
    suppliers to provide acceptable product. Where
    audits are not practical, this may be done
    through, among other means, reviewing historical
    data, monitoring and trending, and inspection and
    testing.

30
Preamble to the 1996 QS RegulationComment 99
  • Thus the degree of supplier control necessary to
    establish compliance may vary with the type and
    significance of the product or service purchased
    and the impact of that product or service on the
    quality of the finished device.

31
Preamble to the 1996 QS RegulationComment 100
  • Thus, a manufacturer must comply with these
    provisions when it receives product or services
    from its sister facility'' or some other
    corporate or financial affiliate. Otherwise
    received product'' would include customer
    supplied product'' as in ISO 90011994, section
    4.7, but would not apply to returned product''
    from the customer.

32
Preamble to the 1996 QS RegulationComment 102
  • FDA believes that all suppliers of such
    services must be assessed and evaluated, just
    like a supplier of a product. As always, the
    degree of control necessary is related to the
    product or service purchased

33
Preamble to the 1996 QS RegulationComment 103
  • certification may play a role in evaluating
    suppliers, but cautions manufacturers against
    relying solely on certification by third parties
    as evidence that suppliers have the capability to
    provide quality products or services. FDA has
    found during inspections that some manufacturers
    who have been certified to the ISO standards have
    not had acceptable problem identification and
    corrective action programs.

34
Preamble to the 1996 QS RegulationComment 103
  • Therefore, the initial assessment or evaluation,
    depending on the type and potential effect on
    device quality of the product or service, should
    be a combination of assessment methods, to
    possibly include third party or product
    certification.

35
Preamble to the 1996 QS RegulationComment 103
  • However, third party certification should not be
    relied on exclusively in initially evaluating a
    supplier. If a device manufacturer has
    established confidence in the supplier's ability
    to provide acceptable products or services,
    certification with test data may be acceptable.

36
Preamble to the 1996 QS RegulationComment 106
  • The intent of Sec. 820.50 is to ensure that
    device manufacturers select only those suppliers,
    contractors, and consultants who have the
    capability to provide quality product and
    services. As with finished devices, quality
    cannot be inspected or tested into products or
    services.

37
Preamble to the 1996 QS RegulationComment 106
  • Rather, the quality of a product or service is
    established during the design of that product or
    service, and achieved through proper control of
    the manufacture of that product or the
    performance of that service

38
Quality System (QS) Regulation21 CFR 820.30
Design Controls
  • 820.30(c) Design Input
  • ensure that the design requirements relating to
    a device are appropriate and address the intended
    use of the device, including the needs of the
    user and patient

39
Quality System (QS) Regulation21 CFR 820.30
Design Controls
  • 820.30(d) Design Output
  • shall contain or make reference to acceptance
    criteria and shall ensure that those design
    outputs that are essential for the proper
    functioning of the device are identified

40
Quality System (QS) Regulation21 CFR 820.30
Design Controls
  • 820.30(g) Design Validation
  • 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...

41
Preamble to the 1996 QS RegulationComment 106
  • Section 820.80 is specific to a device
    manufacturer's acceptance program. While finished
    device manufacturers are required to assess the
    capability of suppliers, contractors, and
    consultants to provide quality products and
    services, inspections and tests, and other
    verification tools, are also an important part of
    ensuring that components and finished devices
    conform to approved specifications.

42
Quality System (QS) Regulation21 CFR 820.80
Acceptance Activities
  • 820.80(a) General
  • Each manufacturer shall establish and maintain
    procedures for acceptance activities. Acceptance
    activities include inspections, tests, or other
    verification activities.

43
Preamble to the 1996 QS RegulationComment 106
  • The extent of incoming acceptance activities can
    be based, in part, on the degree to which the
    supplier has demonstrated a capability to provide
    quality products or services. An appropriate
    product and services quality assurance program
    includes a combination of assessment techniques,
    including inspection and test.

44
Purchasing Controls and Acceptance Activities
Commensurate to the Risk
45
Global Harmonization Task Force (GHTF) Guidance
document
  • GHTF Study Group 3 Final Guidance
  • Quality Management System Medical Devices
    Guidance on the Control of Products and Services
    Obtained from Suppliers
  • Posted Feb. 5, 2009
  • http//www.ghtf.org/documents/sg3/sg3final-N17.pdf

46
Global Harmonization Task Force (GHTF) Study
Group 3
  • Drafting a guidance document
  • Proposed Document for Comment estimated to be
    published in Dec 2009.
  • Quality Management System Medical Devices
    Guidance on corrective action and preventive
    action and related QMS processes

47
Key Terms
  • Correction repair, rework, or adjustment and
    relates to the disposition of an existing
    nonconformity.
  • Corrective Action the action taken to eliminate
    the causes of an existing nonconformity, defect
    or other undesirable situation in order to
    prevent recurrence.
  • Preventative Action action taken to eliminate
    the cause of a potential nonconformity, defect,
    or other undesirable situation in order to
    prevent occurrence.

48
CAPA Summary
49
Providing Industry AssistanceCDRH Resources
  • CDRH Learn New
  • Modules include various premarket and post-market
    information
  • Available 24/7
  • Certificate generated per topic upon passing
    post-tests
  • Suggest Future topics
  • http//www.fda.gov/cdrh/cdrhlearn/
  • Device Advice
  • Self-service website
  • Searchable by topic
  • http//www.fda.gov/cdrh/devadvice/
  • Division of Small Manufacturers, International,
    and Consumer Assistance (DSMICA)
  • Technical Assistance for the Medical Device
    Industry
  • 800-638-2041 or 240-276-3150
  • DSMICA_at_cdrh.fda.gov

50
Providing Industry AssistanceCDRH Learn
  • What is CDRH Learn?
  • New Online Training tool
  • Multi-Media Presentation
  • Available 24/7
  • Certificate generated per topic upon passing
    post-tests
  • Suggest Future topics
  • Examples of Modules
  • Overview of Regulatory Requirements Medical
    Devices
  • Quality System Regulation 21 CFR 820 Basic
    Introduction
  • Overview of the Premarket Notification Process
    510(k)
  • How to Get Your Electronic Product on the U.S.
    Market.
  • BIMO (under development)
  • Registration Listing (under development)
  • http//www.fda.gov/cdrh/cdrhlearn/

51
Thank you!
  • Kimberly Trautman
  • FDAs Medical Device Quality Systems Expert
  • Office of Compliance
  • kimberly.trautman_at_fda.hhs.gov
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