PART V - REGULATORY / ADMINISTRATIVE FOLLOW-UP
Regulatory Philosophy and Strategy
CDRH is generally responsible for the final review of inspections and field tests made under this program and for the issuance of letters resulting from inspections and field tests 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.
Violations of EPRC requirements may include:
- Failure to comply with an applicable performance standard
- Failure to establish and conduct an adequate quality control testing program
- Failure to submit required reports, including initial, model change, annual or accidental radiation occurrence reports
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.
CDRH has classified several potential items of non-compliance that might be observed during an inspection or field test and classified those items in terms of health hazard and regulatory action. Tables are provided in Attachments A – F to provide guidance for use during the inspection or field test, while preparing FDA-483 and EIR or field test reports, and in classifying the inspection or field test and recommending follow-up.
Reporting inspection and test findings
Provide a copy of the completed inspection and test record used during the inspection along with the 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.
Field test reports
Provide a copy of the completed field test record along with a summary of findings.
A table of violations and their health and safety risk as well as the nature of the regulatory response has been provided for each product area.
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.
- 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.
- 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.
- Class C: Labeling or user information fails to comply with a standard.
- Class D: No problems found.
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.
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 major deficiency listed in the specific product noncompliance tables contained in Attachments A – F of this program
- Several observations consisting of minor deficiencies listed in Attachments A – F of this program
The inspection may be classified VAI for a limited number of minor deficiencies listed in Attachments A – F and further regulatory action will be pursued at the discretion of the district and CDRH.
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.
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.
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).
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). A table classifying the severity of items of noncompliance with reporting and recordkeeping, and performance standard requirements is included in Attachments A – F.
Issuance of all letters should follow Chapter 4 of the Regulatory Procedures Manual (RPM). Consult the Office of Enforcement's (OE) Warning Letter page on ORA's intranet for current instructions for obtaining Office of Chief Counsel (OCC) clearance and for current approved Warning Letter templates. 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. Districts do not have direct reference authority to issue letters to manufacturers, addressing EPRC violations alone. CDRH is available for consult in assessing product noncompliance or developing regulatory and enforcement strategy.
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 letters issued and consult on regulatory and enforcement strategy when needed.
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 CFR1010.2 of the regulations. A program disapproval may be issued only by CDRH.
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.
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.
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.
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 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.
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 Electronic Products Branch Chief at 301-796-5863.
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.
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 Electronic Products Branch Chief or Lead CSO at (240) 276-3332.
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.
Medical Device Regulatory / 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 or field test.