Description
This document supersedes MDR Guidance Document and Exemption No. 3 –Needlesticks and Blood Exposure E1996003
Scope & Applicability
Stakeholders
4Individuals at risk from bloodborne pathogen exposure
Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Permitted to continue to submit only written reports to FDA; Entity that may receive requests for additional information from FDA
Regulatory Context
Attributes
1Device failure likely to cause death or serious injury if recurred
Related CFR Sections (3)
- 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 →
- 21CFR803.52§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b) . These types of information correspond generally to the format of Form FDA 3500A: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 →
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
- 2025-01-14
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.
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Rolence Ent. Inc.
See Also (8)
- Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff (Status: Final)
- Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 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)