Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff

Description

FDA is issuing this guidance to provide clarification on its policies and regulatory review expectations for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required to have an approved HDE at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

PMA

For devices subject to PMA requirements, submission of periodic reports is required.

HDE

Humanitarian Device Exemption program

Stakeholders

3

PMA holder

Entity responsible for Class III device submissions.

HDE holder

Entity responsible for HDE submissions.

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Regulatory Activities

8

Premarket Approval

PMA application for high-risk devices

Humanitarian Device Exemption

Marketing submission type requiring QMS information; Regulatory pathway for devices for small patient populations

PMA supplement

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

HDE supplement

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

30-day notice

Submission for modifications affecting safety and effectiveness

180-day PMA supplement

Submission for significant changes to device performance or design

Real-time PMA supplement

Submission for minor changes to manufacturing or design

Periodic report

Annual report for PMA or HDE holders

Document Types

1

Device Master Record

Documentation where changes and approvals must be recorded

Attributes

1

Sterility Assurance Level

Quality parameter that must remain unchanged for the policy

Technical Details

Substances

1

Ethylene oxide

Sterilization agent for Class III devices.

Testing Methods

2

Software Verification

Verification of software/firmware changes

Functional Testing

Testing required for component changes

Processes

2

Sterilization

Required for contaminated equipment and media before disposal

Automation

Automation of existing processes that are fully verified

Clinical Concepts

1

Coronavirus Disease 2019

The COVID-19 pandemic and public health emergency.

Identified Hazards

Hazards

3

Supply chain disruptions

Reason for exercising enforcement discretion.

Device shortages

Public health equity concern addressed by the policy.

COVID-19 public health emergency

Context for the enforcement policy

Related CFR Sections (4)

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 →
21CFR814.108§ 814.108 Supplemental applications.
After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39 , except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110 . The timeframes for review of, and FDA actionRead full regulation →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR814.84§ 814.84 Reports.
(a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device.Read 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