FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7382.845

SUBJECT:

INSPECTION OF MEDICAL DEVICE MANUFACTURERS

IMPLEMENTATION DATE

February 2, 2011

COMPLETION DATE

February 2, 2015

DATA REPORTING

PRODUCT CODES PRODUCT/ASSIGNMENT CODES

73-91 82845A; 42845A All Level 1 (Abbreviated) Inspections

82845B; 42845B All Level 2 (Comprehensive) Inspections

82845C; 42845C All Level 3 (Compliance Follow-up) Inspections

82845G All For Cause Inspections

82845H Risk Based Work Plan Inspections

82845P Joint FDA/Accredited Person Inspections

82845S Report Time spent on Assessment of Firms Sterilization processes

81010 Report Time spent on MDR Follow-up

81011 Report Time spent on Assessment of Firms MDR Practices

81845T Report Time spent on Assessment of Firms Tracking Practices

81845R Report Time spent on Assessment of Firms Corrections and Removals Practices

82A800 Independent Accredited Person Inspections

* Previous editions obsolete.

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FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7382.845

Index for Compliance Program 7382.845

Coversheet Field Reporting Requirements

Part I Background A. The Quality System (QS) Regulation B. The MDR Regulation C. The Medical Device Tracking Regulation D. The Corrections and Removals Regulation E. The Registration and Listing Regulation

Part II Implementation A. Objectives B. Program Management Instructions

Part III Inspectional A. Operations

1. Inspectional Strategy a. QS inspections b. Level 1 Inspections c. Level 2 Inspections d. Level 3 Inspections e. For Cause Inspections f. Risk Based Work Plan Inspections g. Foreign Inspections

2. Inspectional Instructions 3. Special Instructions Concerning Design Controls 4. Special Instructions for Sterilization Processes 5. Inspection of Radiation Emitting Devices 6. Sample Collection

B. Additional Considerations 1. Registration and Listing 2. Imports 3. Exports 4. Electronic Records and Electronic Signatures

C. Remarketed Devices D. Reporting

Part IV Analytical A. Analyzing Laboratories B. Analyses to be Conducted C. Methodology

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Part V Regulatory/Administrative Follow-up A. Quality System/GMP Regulatory/Administrative Follow-up

1. Compliance Decision 2. Contract Sterilizers, Contract Device Manufacturers and

Finished Device Manufacturers Deciding Responsibility When Taking Regulatory Action

3. Violative Devices Sold to Government Agencies 4. Administrative and Judicial Actions 5. Facilitating Review of Regulatory Recommendations

B. MDR Regulatory/Administrative Follow-up C. Tracking Regulatory/Administrative Follow-up D. Corrections and Removals Regulatory/Administrative Follow-up E. Registration and Listing Regulatory/Administrative Follow-up F. Radiation Emitting Device Regulatory/Administrative Follow-

up G. Exports Regulatory/Administrative Follow-up

Part VI References and Program Contacts

Attachments

Attachment A CDRH Office of Compliance Organizational Chart

Attachment B CDRH Office of In Vitro Diagnostic Devices Organizational Chart

Attachment C Summary of MDR Reporting Requirements

Attachment D Summary of Tracking Requirements

Attachment E Summary of Corrections and Removals Requirements

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FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7382.845

Field Reporting Requirements

EIRs: All recommendations for administrative/regulatory action should include the EIR, FDA-483 and exhibits. The recommendations should be sent to the Center for Devices and Radiological Health (CDRH) and for tissue or combination products the recommendations should also be sent to the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER) as appropriate.

Note: If the district wishes to obtain comment from CDRH for any EIR, the district should attach a cover memorandum to the EIR outlining the issues to be considered by the Office of Compliance (OC) or Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).

This guidance document represents the agencys current thinking on the enforcement of the Quality System (QS), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals, and the Registration and Listing regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

PAC Guidance

PROGRAM PACs Quality System Level 1 (82845A)

Level 2 (82845B) Level 3 (82845C)

For Cause 82845G Risk Based Work Plan 82845H Joint FDA/Accredited Persons

82845P

Independent Accredited Person Inspection

82A800

MDR 81010 & 81011 Tracking 81845T CAR 81845R Sterilization Inspections 82845S

Note: When conducting sterilization review as part of the Production and Process Controls subsystem, report only the time spent reviewing the sterilization process during the Quality System inspection, if covered under PAC 82845S. Also, report PACs, 81010, 81011, 81845T and 81845R, as applicable.

The above PAC Guidance is provided for investigator reference only. Additional CBER and/or CDER PAC codes may also by necessary for multi-jurisdictional products (i.e. tissue and combination products). Please refer to the inspection assignment for guidance.

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FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7382.845

PART I

BACKGROUND

This compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System (QS) regulation (21 CFR Part 820), the Medical Device Reporting (MDR) regulation (21 CFR Part 803), the Medical Device Tracking regulation (21 CFR Part 821), the Corrections and Removals regulation (21 CFR Part 806), and the Registration and Listing regulation (21 CFR Part 807). This compliance program supersedes the program of the same name which was issued on June 15, 2006.

This compliance program encompasses five regulations for inspecting medical device firms. Under the QS regulation, manufacturers are expected to control their devices from design stage through post-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed. This compliance program provides specific guidance for each. It also requires coverage for the Registration & Listing regulation.

A. THE QUALITY SYSTEM (QS) REGULATION

Manufacturers establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as Current Good Manufacturing Practices (CGMP's). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), which was among the authorities added to the act by the Medical Device Amendments of 1976. Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for the methods used in, and the facilities and controls used for the manufacture, packing, storage, and installation of medical devices. This regulation became effective on December 18, 1978.

The Safe Medical Devices Act of 1990 (the SMDA), enacted on November 28, 1990, amended section 520(f) of the act, providing FDA with the authority to add preproduction design controls to the CGMP regulation. This change in law was based on findings that a significant proportion of device recalls were attributed to faulty design of product. The SMDA also added new section 803 to the act (21 U.S.C. 383) which, among other things, encourages FDA to work with foreign countries toward mutual recognition of CGMP requirements. FDA undertook the revision of the CGMP regulation to add the design controls authorized by the SMDA to the CGMP regulation and because the agency believed that it would be beneficial to the public and the medical device industry for the CGMP regulation to be consistent, to the extent possible, with the requirements for quality systems contained in applicable international standards. FDA published the revised CGMP requirements in the final rule entitled Quality System Regulation in the Federal Register of October 7, 1996 (61 FR 52602). This regulation became effective on June 1, 1997 and remains in effect.

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B. THE MDR REGULATION

The first Medical Device Reporting (MDR) regulation became final on December 13, 1984. As a result of changes mandated by the Safe Medical Devices Act (SMDA) of 1990, and the Medical Device Amendments o