Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff

Description

This guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the "combination product PMSR final rule," "final rule," or "rule").  The rule describes how to comply with PMSR requirements for combination products that have received FDA marketing authorization.  Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes.  The final rule addresses the application of these regulatory requirements to combination products to ensure consistent and complete reporting while avoiding duplication.

Scope & Applicability

Regulatory Context

• 21CFR803.19§ 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

  (a) We exempt the following persons from the adverse event reporting requirements in this part:Read full regulation →

• 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.

  (a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →

• 21CFR803.56§ 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

  If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this inRead full regulation →

• 21CFR806.20§ 806.20 Records of corrections and removals not required to be reported.

  (a) Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.10 shall keep a record of such correction or removal.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 →

• 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 →

• 21CFR4.102§ 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 →

• 21CFR4.103§ 4.103 What information must you share with other constituent part applicants for the combination product?

  (a) When you receive information regarding an event that involves a death or serious injury as described in § 803.3 of this chapter , or an adverse experience as described in § 314.80(a) of this chapter or § 600.80(a) of this chapter , associated with the use of the combination product, you must proRead full regulation →

• 21CFR806.10§ 806.10 Reports of corrections and removals.

  (a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:Read full regulation →

• 21CFR606.171§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.

  (a) Who must report under this section? You, a licensed manufacturer of blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, must report under this section. If you arrRead full regulation →

• 21CFR600.14§ 600.14 Reporting of biological product deviations by licensed manufacturers.

  (a) Who must report under this section?Read full regulation →

• 21CFR314.81§ 314.81 Other postmarketing reports.

  (a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

• 21CFR803.3§ 803.3 How does FDA define the terms used in this part?

  Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:Read full regulation →

• 21CFR3.2§ 3.2 Definitions.

  For the purpose of this part:Read full regulation →

• 21CFR4.100§ 4.100 What is the scope of this subpart?

  (a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants.Read full regulation →

• 21CFR4.101§ 4.101 How does the FDA define key terms and phrases in this subpart?

  Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter .Read full regulation →

• 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.

  (a) Definitions. The following definitions of terms apply to this section:Read full regulation →

• 21CFR803.53§ 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?

  You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that:Read full regulation →

• 21CFR803.50§ 803.50 If I am a manufacturer, what reporting requirements apply to me?

  (a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a) , no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a deviRead full regulation →

• Compounding Pharmacy/Adulterated Drug Products

  Wells Pharma of Houston, LLC

  2025-11-25

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Royal Philips

  2025-10-28

• Medical Device Reporting/Misbranded

  Insung Medical Co. Ltd.

  2025-09-30

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Visgeneer, Inc

  2025-08-05

• Medical Device Reporting/Misbranded

  Insightra Medical Inc.

  2025-07-08

• CGMP/QSR/Medical Devices/Adulterated

  Aju Pharm Co., Ltd.

  2025-06-24

• False & Misleading Claims/Misbranded

  Sprout Pharmaceuticals, Inc.

  2025-06-10

• CGMP/QSR/Medical Devices/Adulterated

  DFI Co., Ltd.

  2025-06-03

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