Inspection of Medical Device Manufacturers

1 Inspection of Medical Device Manufacturers Document issued on: June 15, 2006 PROGRAM SUBJECT: Inspection OF Medical Device Manufacturers IMPLEMENTATION DATE: June 15, 2006 (Previous editions obsolete.) COMPLETION DATE: June 15, 2010 DATA REPORTING PRODUCT CODES: 73-91 PRODUCT/ASSIGNMENT CODES: 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 82845P -- Joint FDA/Accredited Person Inspections 82845S -- Report Time spent on Assessment of Firm s Sterilization processes 81010 -- Report Time spent on MDR Follow-up 81011 -- Report Time spent on Assessment of Firm s MDR Practices 81845T -- Report Time spent on Assessment of Firm s Tracking Practices 81845R -- Report Time spent on Assessment of Firm s Corrections and Removals Practices 82A800 -- Independent Accredited Person Inspections Index for Compliance Program Coversheet: Field Reporting Requirements Part I: Background 1.

2 The Quality System (QS) Regulation 2. The MDR Regulation 3. The Medical Device Tracking Regulation 4. The Corrections and Removals Regulation 5. The Registration and Listing Regulation Part II: Implementation 1. Objectives 2. 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. 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.

3 Registration and Listing 2. Imports 3. Exports 4. Electronic Records and Electronic Signatures C. Remarketed devices D. Reporting Part IV: Analytical 1. Analyzing Laboratories 2. Analyses to be Conducted 3. Methodology 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.

4 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 Field Reporting Requirements EIRs: All recommendations for administrative/regulatory action should include the EIR, FDA-483, and exhibits.

5 The recommendations should be sent to the Center for devices and Radiological Health (CDRH) HFZ-306 and for human cells, tissues, and cellular and tissue-based products (HCT/Ps), 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. Warning Letters: A copy of all Warning Letters related to all requirements covered in this compliance program should be sent to HFZ-306 and HFC-210. Comment: 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).

6 This guidance document represents the agency s 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 Level 1 (82845A) Level 2 (82845B) Quality System Level 3 (82845C) For Cause 82845G 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.

7 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 ( tissue) and combination products. Please refer to the Inspection assignment for guidance 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 Remov als regulation (21 CFR Part 806), and the Registration and Listing regulation (21 CFR Part 807).

8 This compliance program supersedes the program of the same name which was issued on October 1, 2000. This compliance program encom passes 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.

9 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 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 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 .

10 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 (21 383) 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, as well as 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.