Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A

Description

The following items are common to all EPRC inspections and field tests, and may be cited for any product subject to the below reporting or certification requirements. Products subject to reporting are listed in Table 1 of 1002.1, and certification requirements are applicable to all products subject to a performance standard.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Stakeholders

1

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Regulatory Context

Regulatory Activities

10

Premarket Approval Application

Marketing submission type requiring QMS information; Type of marketing submission requiring QMS information

510(k)

Premarket notification submission type

Preapproval Inspection

Inspection conducted before drug approval

PMA supplement

Required for changes affecting safety and effectiveness.; Submission for modifications to an approved PMA

panel-track supplement

Supplement for significant changes in design or performance requiring clinical data.

180-day supplement

Supplement for significant changes in components, materials, or software.

real-time supplement

Type of PMA submission typically not requiring inspection.

30-day notice

Submission for modifications affecting safety and effectiveness

PMA annual report

Periodic report for approved PMAs.

PMA

Premarket Approval Application

Document Types

5

PMA Manufacturing Section

Information regarding manufacturing operations in a PMA

establishment inspection report

Document where registration info is recorded

deficiency letter

Identifies deficiencies that the applicant must address.

Warning Letter

Notification to a manufacturer regarding significant violations of FDA regulations.; Agency's principal means of achieving prompt voluntary compliance.

Untitled Letter

Issued for objectionable conditions that warrant regulatory sanctions

Attributes

1

safety and effectiveness

Primary outcomes to be measured in the study

Technical Details

Processes

1

manufacturing operations

Activities reviewed for deficiencies during the PMA process.

Clinical Concepts

1

clinical data

Data necessary for panel-track supplements and safety assurance.

Standards & References

External Standards

2

Medical Device User Fee and Modernization Act of 2002

Legislation that amended the FD&C Act to codify modular review.

MDUFMA

Medical Device User Fee and Modernization Act performance goals

Specifications

1

acceptance criteria

Criteria for security architecture and design outputs.

Related CFR Sections (2)

21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

21

Misbranded under section 502(o)

19

Failure to establish and maintain procedures to control the design of the device

10

Failure to adequately develop, maintain, and implement written MDR procedures

10

Failure to establish and maintain procedures for implementing corrective and preventive action

10

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Unapproved Device Violations

8

Failure to establish and maintain procedures for implementing corrective and preventive actions

8

Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures