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Regulatory pathway for labeling combination products as sterile 237

[6] Regulation (EC) No 726/2004 of the European Parliament and of the Council
of 31 March 2004 Laying down Community Procedures for the Authorisation and
Supervision of Medicinal Products for Human and Veterinary Use and Establishing a
European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
[7] European Medicines Agency, EMA/CHMP/CVMP/QWP/BWP/850374/2015,
Guidance on the sterilization of the medicinal product, active substance, excipient and
primary container.
[8] ISO TS 19930: 2017 Guidance on aspects of a risk-based approach to assuring sterility
of terminally sterilized, Single-Use Health Care Product Including that Unable to
−6
Withstand Processing to Achieve Maximally a Sterility Assurance Level of 10 .
[9] AAMI ST67: 2019, Sterilization of Health Care Products – Requirements and Guid-
ance for Selecting a Sterility Assurance Level (SAL) for Products Labeled “Sterile”.
[10] ISO 13408-1: 2006, Aseptic processing of health care products—Part 1: General re-
quirements.
[11] ISO 13408-7: 2012, Aseptic processing of health care products—Part 7: Alternative
processes for medical devices and combination products.
[12] EN 556-1:2001, Sterilization of Medical Devices — Requirements for Medical De-
vices to Be Designated “STERILE”—Part 1: Requirements for Terminally Sterilized
Medical Devices.
[13] EN 556-2:2015, Sterilization of Medical Devices—Requirements for Medical Devices
to Be Designated “STERILE”—Part 2: Requirements for Aseptically Processed Med-
ical Devices.
[14] FDA Guidance Document, “Factors to Consider When Making Benefit-Risk Deter-
minations for Medical Device Investigational Device Exemptions”, 2017.
[15] FDA Guidance Document, “Factors to Consider When Making Benefit-Risk Deter-
minations in Medical Device Premarket Approval and De Novo Classifications”, 2016.
[16] FDA Guidance Document, “Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program—Guidance for Industry and Food
and Drug Administration Staff”, 2019.
[17] FDA Guidance Document, “Submission and Review of Sterility Information in Pre-
market Notification (510(k)) Submissions for Devices Labeled as Sterile – Guidance
for Industry and Food and Drug Administration Staff”, 2016.