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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment - Part V: Regulatory / Administrative Strategy

PART V - REGULATORY / ADMINISTRATIVE FOLLOW-UP

  1. Regulatory Philosophy and Strategy

    Diagnostic X-ray equipment is subject to radiation safety performance standards and is regulated under Subchapter C - Electronic Product Radiation Control of the FFDCA. Subchapter C provides authority to require product recalls for noncompliant or defective radiation-emitting electronic products. EPRC provisions specify that, for violations of sufficient severity, the Secretary of FDA may require the manufacturer to repair, replace or refund the cost of the violative products at no cost to the user/purchaser. In addition, because products covered under this compliance program are also medical devices, Subchapter A – Drugs and Devices of the FFDCA provides authority to require product recalls for medical devices that may cause a serious risk to health.

    Violations of the EPRC provisions include:

    • Introduction into commerce of any electronic product which is defective or does not comply with an applicable standard
    • Failure to maintain or submit required reports
    • Failure to maintain or make available distribution records
    • Failure to certify products as compliant
    • False certification of products.

    When there is a choice, regulatory/administrative action is preferred under Subchapter C, but, for maximum effectiveness, both EPRC and medical device portions of the FFDCA may be used in conjunction.

    Appropriate regulatory or administrative actions include issuance of a notification of defect or non-compliance letter (warning or untitled letter), requiring repurchase, repair or replacement of product under an approved corrective action plan, or imposition of civil penalties and/or injunction. Appropriate follow-up actions should be determined by CDRH or in consultation with CDRH to ensure consistency in how EPRC requirements are enforced.

    Districts classify the EIRs and CDRH is generally responsible for the final review of inspections made under this program and for the issuance of letters resulting from inspections performed by field radiological health staff. Exceptions where the district has direct reference authority are noted below under section C, Regulatory Action. The intent of this program is to follow up on problems that pose a radiation safety hazard or are a flagrant violation of EPRC requirements.

  2. District Responsibilities

    1. Reporting inspection and test findings

      1. Inspection reports

        Provide a copy of Establishment Inspection Report (EIR) and exhibits. Refer to the IOM for EIR formats, and clearly indicate the scope of the inspection in the EIR. Document any corrections performed during the inspection or corrections promised with the timeframe for completion.

    2. Recommending Action

      1. Hazard Class for Non-Compliance

        Class A, B, C, and D refer to the hazard class of the observations, related to the severity of the threat to health and safety posed by a particular non-compliant product or practice. Attachment D of Compliance Program 7386.003 for Field Compliance Testing of Diagnostic (Medical) X-ray Equipment contains a more detailed discussion of Class A and B observations, with examples provided below.

        • Class A: Conditions that pose an immediate radiation hazard to health and safety. Notify CDRH/OCER contacts identified in Part VI of this program immediately to discuss appropriate action to stop production or product use until corrective action has been taken. Consider contacting State Health Department or other local contacts to assist in addressing problems with product use, if warranted.

          For example, Class A conditions include equipment malfunctions or quality control deficiencies resulting in the occurrence of an inadvertent exposure, excessive fluoroscopic exposure, or inadequate protective barriers to limit fluoroscopic exposure.

        • Class B: Conditions that include radiation safety defects or items of noncompliance with the standard which, without corrective action, could pose a radiation hazard if the non-compliance or defect is not addressed.

          For example, Class B conditions include equipment malfunctions or quality control deficiencies resulting in the occurrence of an excessive or insufficient (i.e. unusable, requiring a retake) exposure, or resulting in violations of established performance standard exposure limits.

          Specific examples of Class B violations are discussed in Attachment D of Compliance Program 7386.003 in further detail.

        • Class C: Labeling or user information fails to comply with a standard.

        • Class D: No problems found.

      2. Regulatory Response to Non-Compliance

        The designations of a violation as Major, Minor, or Concern refer to the level of regulatory response required to correct deficiencies.

        • Major: Non-compliance with a standard that always warrants regulatory action such as a warning letter.
        • Minor: Non-compliance with a standard about which a manufacturer should be informed but is not severe enough to warrant a warning letter.
        • Concern: Non-compliance which is not severe enough to mention unless also informing a manufacturer about a Major or Minor item.
      3. Inspection Classification

        Based on inspectional findings, the district will classify the inspection as OAI, VAI or NAI for further action.

        If any major EPRC deficiencies exist, the district is expected to classify the inspection as OAI and recommend further regulatory action. Examples of findings that would result in an OAI classification include:

        • Total failure to establish a quality control testing program capable of ensuring radiation safety of the product or compliance with applicable performance standards.
        • Any single observation of a Class A condition
        • Several observations consisting of Class B conditions

        The inspection may be classified VAI for a limited number of Class B and C conditions, which are not expected to pose a radiation hazard if corrected voluntarily by the manufacturer.

        If it is determined that the EPRC deficiencies are of a quantity and type to conclude there is minimal probability that the firm will produce unsafe or noncompliant products, the inspection will be classified NAI and Form FDA-483 will serve to inform the firm of any objectionable findings. Deficiencies identified as violations of concern will generally not require additional follow-up but should be discussed with the firm. Examples of deficiencies that would result in an NAI classification include:

        • QC & T data exceed the test rejection limit but do not exceed the requirement(s)of the performance standard(s) applicable to the product under inspection;
        • Failure to submit annual reports in a timely manner
        • Using test equipment past calibration due date

        Consult CDRH if additional guidance is required to classify inspection and test observations. If the inspection also covered firm compliance with medical device Quality Systems requirements, Compliance Program 7382.845, Part V, Quality System/GMP Regulatory/Administrative Follow-Up, should be consulted for appropriate regulatory and administrative follow-up.

  3. Regulatory Action

    In determining appropriate regulatory action based on inspection and test findings, the district and CDRH should consider the significance of the product, the firm's history, whether the problem is widespread and continuing. Actions which may be considered include notification of noncompliance letters (warning and untitled letters), product repurchase, repair or replacement (recall), civil penalties and injunctions, and seizures (for radiation-emitting medical devices).

    1. Notification of noncompliance letters (Warning and Untitled Letters)

      The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1003) require the Agency to notify manufacturers in writing when product noncompliance with a standard is found. Manufacturers may also be advised in writing of a failure to comply with reporting and recordkeeping requirements (21 CFR 1002.31).

      Issuance of all letters should follow Chapter 4 of the Regulatory Procedures Manual (RPM). Consult the Warning Letter procedures in the RPM (Ch 4, Ex 4-1) for current instructions for obtaining Office of Chief Counsel (OCC) clearance; and the Office of Enforcement's (OE) Warning Letter page on ORA's intranet for templates and model letters approved by OCC. Letter templates must be used to satisfy Agency notification requirements in 21 CFR 1003.11. Where approved OCC templates are not available, consult CDRH for the current version of letter templates.

      Districts have DIRECT REFERENCE AUTHORITY for EPRC letters in certain areas which are described in Chapter 4 of the RPM. For example, districts have direct reference authority to issue warning and untitled letters to assemblers of diagnostic x-ray equipment based on field test results; and may approve corrective action plans for x-ray assemblers.

      For the majority of cases, where districts DO NOT have direct reference authority to issue EPRC letters, forward the report with exhibits and recommended action to CDRH for review and follow-up. CDRH will copy the accomplishing district on any such letters issued.

      If the letter should contain both medical device and EPRC violations contact CDRH to discuss options for follow-up. For example, issuance of a single letter by the district, addressing both EPRC and medical device violations, may be possible with CDRH concurrence. CDRH is available for consult in assessing product noncompliance or developing regulatory and enforcement strategy.

      1. Major Notification of Noncompliance Letter (Warning Letter)

        This letter notifies the firm of major items of noncompliance and requires the firm to further notify purchasers and recall products. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval.

        Issue a major notification (warning) letter when the violation of the standard requires further regulatory action.

        • All major violations must be addressed in a warning letter.
        • Firms and products with several minor violations may also be issued a major notification letter, depending on the public health significance of the violation(s) and the number of products involved.
        • Violations of concern may also be included in a major notification (warning) letter, but would not warrant issuance of a major notification (warning) letter on their own merit.

        The firm's quality control testing program may be also be disapproved upon issuance of a major notification letter, when the Agency believes that the manufacturer's quality control and testing program is not following good manufacturing practices. A program disapproval orders the manufacturer to cease certification of products (i.e. stop production and testing) until the program disapproval is rescinded, and places the firm's products on automatic import detention without prior examination, under authority of Section 534(h) of the Act and 21 CFR 1010.2 of the regulations. A program disapproval may be issued only by CDRH.

      2. Minor Notification of Noncompliance Letter (Untitled Letter)

        This letter notifies the firm of minor items of noncompliance and exempts the firm from further notifying purchasers and recalling products. The firm is instructed to address all items in the letter and make appropriate corrections for future production.

        Issue a minor notification (untitled) letter when the violation of the standard does not justify further regulatory action at the time.

        • Firms and products with a limited number of minor violations may be issued a minor notification letter, depending on the public health significance of the violation(s) and the number of products involved.
        • Violations of concern may also be included in an untitled letter, but would not warrant issuance of an untitled letter on their own merit.
      3. Information Letter

        This letter is a tool used only for CDRH follow-up with manufacturers where conditions represent potential problems and no additional action is planned. Information letters advise manufacturers of inspectional findings and request a response to indicate completed or planned corrections.

        Issue an information letter when no immediate action is required of the manufacturer or when the violation is administrative in nature.

        • Firms that have not filed annual reports may be issued an information letter
        • Violations of concern may also be included in an information letter, to advise the firm of inspectional findings and request status of promised corrections
    2. Repurchase, Repair, or Replacement of Electronic Products (Recall)

      The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1004) also provide for manufacturer repurchase, repair or replacement of the noncompliant electronic products.

      Every major notification of noncompliance letter issued as a result of a major violation or several minor violations requires manufacturer repurchase, repair or replacement of the affected electronic products at no cost to the purchaser. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval. Refer to RPM Chapter 7, Attachment E for approval of manufacturer's corrective action plans.

    3. Refutation or Exemption from Notification or Correction Requests

      Manufacturers can refute the noncompliance or be granted an exemption, by making a written request to CDRH. The exemption can be granted upon request by the manufacturer or by the Agency at its own initiative, and must show that the noncompliance does not create a significant risk of injury.

      Within 15 days after notification of the noncompliance/defect by FDA, a manufacturer may refute the alleged noncompliance under 21 CFR 1003.11(a)(3) or request an exemption from purchaser notification and correction as specified under 21 CFR 1003.30. If a manufacturer refutes the alleged noncompliance, or requests an exemption, the evidence presented by the manufacturer is evaluated by CDRH before granting or denying the request for exemption or responding to the refutation. Refer to RPM Chapter 7, Attachment E for information on responding to exemption requests and refutations.

    4. Timeframes for action

      Immediately notify CDRH and State and local health authorities (through RRHR) for any Class A hazard.

      For all inspections and tests that may require issuance of a letter, the EIR must be completed in a timely manner and recommendation should be provided to CDRH or the district compliance officer to allow sufficient time to review, draft, and secure approval for the letter. Timeframes for clearance of letters are provided in Chapter 4 of the RPM.

    5. Civil Penalties/Injunctions

      Civil penalties should be recommended for violations of Subchapter C of the Act after other actions have failed to achieve compliance, or for knowing and willful violations. More severe civil penalty assessments may be sought under Section 303(f). See CPG Sec. 390.300 and RPM Chapter 6, Civil Penalties - Electronic Product Radiation Control. Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged in order to facilitate timely implementation of the action; contact Diagnostic Devices Branch Chief at (301) 796-5712.

      If an establishment has a continuing pattern of significant deviations in spite of past warnings, injunction will usually be the recommended action of choice. If a serious health hazard exists, the recommendation should include a request for a temporary restraining order (TRO) to prevent the distribution of products that have been manufactured under the violative conditions documented by the inspection report per the instructions in Chapter 6 of the RPM. Civil penalties and injunctions may be recommended concurrently.

    6. Detention/Seizure

      Use administrative detention and recommend seizure of a defective or noncompliant radiation-emitting medical device if all three conditions below apply:

      • There is a Class A health hazard
      • The owner/operator refuses to remove the product from service or returns the product to use before the Class A hazard is corrected
      • The EPRC provisions are ineffective in achieving timely correction by the manufacturer

      Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged; contact Diagnostic Devices Branch Chief at (301) 796-5712.

  4. Federal / State Relations

    Some states have Radiation Control Programs within the State Health Department or Department of Environmental Health, which may have adopted portions of the EPRC requirements into their radiation safety regulations.

    Districts should use all reasonable means available to encourage voluntary conformance of products with the performance standard regardless of the date of manufacture. It is recommended that the districts coordinate regulatory activity with appropriate state representatives through the RRHR and DFSR, particularly where local authority may assist in achieving correction of a deficiency. This may be particularly useful to address issues related to product use where the State may have regulatory authority, which extends beyond FDA authority to regulate the design, production or manufacture of the product.

  5. Medical Device Regulartory / Administrative Follow-Up

    Regulatory follow-up for joint EPRC/quality systems inspections can be handled separately or in combination at the discretion of the district and CDRH. Refer to Part V in Compliance Program 7382.845, Quality System/GMP Regulatory/Administrative Follow-Up, for guidance on regulatory actions related to radiation-emitting medical devices. Enforcement actions on radiation-emitting medical device firms, which also include EPRC violations, require CDRH concurrence before implementation by the field. Contact CDRH for consultation when both EPRC and quality systems violations are noted during an inspection.