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
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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

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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.

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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.

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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.

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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,

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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.

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CAPA Summary
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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

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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/

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Thank you!

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