Description
This guidance document is intended to assist Combination Product Applicants who are subject to the Combination Product Postmarketing Safety Reporting Final Rule (hereafter “combination product PMSR final rule,” “final rule,” or “rule”), issued on December 20, 2016 (81 FR 92603), and codified in 21 CFR Part 4, Subpart B. This guidance document discusses FDA’s compliance policy for the rule. FDA does not intend to enforce certain requirements under the rule, specifically 21 CFR 4.102(c) and (d), 4.104(b)(1) and (b)(2), and 4.105(b), for a period of time as discussed further in section III below. FDA intends to delay enforcement of these provisions to ensure that Combination Product Applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with these requirements, and in doing so, have sufficient time to consider the recommendations and technical specifications that FDA intends to provide through guidance to support compliance. For all other provisions of 21 CFR Part 4, Subpart B, FDA intends to enforce (or continue enforcing) the requirements per its usual policies as of the compliance date provided in the final rule.
Scope & Applicability
Product Classes
1Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2Entity subject to the PMSR final rule for a constituent part of a combination product.; Entity holding an application for a constituent part marketed by different applicants; Entity responsible for a specific part of a combination product.; Entities required to share information regarding deaths or serious injuries; Subject to separate recordkeeping and information sharing requirements.; Entity subject to the combination product PMSR final rule
Entity subject to the PMSR final rule for a combination product.; Entity holding the only application or all applications for a combination product; Entity responsible for safety reporting for the combination product as a whole.; Entity responsible for submitting safety reports; Entity responsible for submitting PMSR reports for combination products; Must retain PMSR records for the longest time period required under all applicable requirements.; Entity responsible for submitting combined FAR/BP
Related CFR Sections (6)
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR4.105§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
(a) If you are a constituent part applicant:Read full regulation →
- 21CFR4.104§ 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?
(a) If you are a constituent part applicant, you must submit postmarketing safety reports in accordance with the regulations identified in § 4.102(b) that are applicable to your product based on its application type.Read full regulation →
- 21CFR4.102§ 4.102 What reports must you submit to FDA for your combination product or constituent part?
(a) In general. If you are a constituent part applicant, the reporting requirements applicable to you that are identified in this section apply to your constituent part, and if you are a combination product applicant, the reporting requirements applicable to you that are identified in this section aRead full regulation →
Related Warning Letters (10)
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-07-08
Medical Device Reporting/Misbranded
Insightra Medical Inc.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-06-03
CGMP/QSR/Medical Devices/Adulterated
DFI Co., Ltd.
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2025-03-18
CGMP/Finished Pharmaceutical/Adulterated
Advanced Pharmaceutical Technology
- 2025-01-14
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Hologic, Inc.
- 2024-12-24
CGMP/QSR/Medical Devices/Adulterated
Rontis Hellas S.A.
- 2024-12-17
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Becton, Dickinson, and Company/CareFusion 303, Inc.
See Also (8)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Suggested Format For IDE Progress Report (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
- Medical Device Reporting for User Facilities (Status: Final)
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)
- Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (Status: Final)
- Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (Status: Final)