shimonv
Trusted Information Resource
Hi All,
For those of you who have not read the recent guidance document (attached), I wrote a summary of the main points using the text from the guidance.
If you are wise, keep away from it.
Cheers,
Shimon
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Overview
1. Section 522 of the Act, 21 U.S.C. § 360l, authorizes FDA to require postmarket surveillance in the following instances:
• a class II or class III device for which failure of the device would be reasonably likely to have a serious adverse health consequence (section 522(a)(1)(A)(i) of the Act);
• a class II or class III device expected to have significant use in pediatric populations (section 522(a)(1)(A)(ii) of the Act);
• a class II or class III device intended to be implanted in the human body for more than one year (section 522(a)(1)(A)(iii)(I) of the Act); or
• a class II or class III device intended to be a life-sustaining or life-supporting device used outside of a user facility (section 522(a)(1)(A)(iii)(II) of the Act)
2. Section 522(a)(1)(A) of the Act specifies that the agency may issue a postmarket surveillance order at the time of device approval or clearance or any time thereafter.
3. The order of prospective postmarket surveillance period can be up to 36 months and sometimes even more.
The process
4. FDA may identify device issues that are appropriate for postmarket surveillance at any point during the life cycle of a device. Such issues may be identified through a variety of sources including analysis of adverse event reports, a recall or corrective action, post-approval data, review of premarket data, reports from other governmental authorities, or review of scientific literature.
5. When FDA identifies a potential issue with a device that may warrant postmarket surveillance, the Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB), Center for Devices and Radiological Health (CDRH) makes a determination regarding whether the statutory requirements for a section 522 order have been met. Next, the Division establishes a cross-Center team (i.e., pre-522 team) to review the issue in greater depth. This team may include FDA epidemiologists, clinicians, or other experts as needed to assess the issue. The pre-522 team evaluates numerous elements with the ultimate goal of making a recommendation to the DEPI Division Director and OSB Director as to whether or not a 522 order should be issued to address a public health question.
6. An order for postmarket surveillance under section 522 of the Act will generally be issued by the OSB Director. The 522 order should identify the premarket submission involved (i.e., 510(k), PMA, PDP, or HDE, or de novo petition), the public health questions, the rationale for the 522 order, and postmarket surveillance design recommendations to assist the manufacturer subject to the 522 order in preparing the postmarket surveillance plan. See 21 CFR 822.5. If a manufacturer disagrees with any order or condition requiring postmarket surveillance under section 522 of the Act, possible recourse options are described in 21 CFR 822.7.
7. FDA will assign a postmarket surveillance (PS) number (i.e., PS######) to each 522 order.
8. A manufacturer must submit a postmarket surveillance plan within 30 days of receipt of the 522 order and commence surveillance not later than 15 months after the day on which FDA issues the 522 order.
9. The general and specific content for a postmarket surveillance submission, including the surveillance plan, is outlined in 21 CFR 822.9 and 822.10. FDA will review all postmarket surveillance submissions and respond within 60 calendar days.
10. If a manufacturer disagrees with FDA about the content of the plan or if the plan is disapproved, possible recourse options are described in 21 CFR 822.22.
11. If a manufacturer wishes to propose a change to an approved postmarket surveillance plan that will affect the nature or validity of the data collected, the manufacturer must obtain FDA approval in writing before making such changes.
12. Failure to comply with a requirement under section 522 of the Act may result in enforcement action by FDA.
13. There are different types of postmarket surveillance: randomized clinical trials, prospective cohort study, retrospective cohort Study, cross-sectional study, enhanced surveillance, active surveillance, comprehensive, linked, registry-based surveillance, meta-analysis, prospective & retrospective study, case control study, bench/lab study, animal study, or other design.
14. As provided at 21 CFR 822.38, manufacturers must submit interim and final reports as specified in an approved postmarket surveillance plan.
15. FDA’s 522 webpage - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm.
Summary
• In a nutshell, it is somewhat similar to the EU post-market clinical follow-up (PMCF) process only a lot more stringent.
• This guidance document authorizes FDA to order manufacturers to do postmart surveillance when one of the criteria set in point #1 are met, and when the agency believes that there is a public health question that must be addressed.
• It's good to keep an eye on FDA's 522 page to see who is getting such an order and way.
• The amount of effort required to fulfill a postmarket surveillance is enormous. It would be wise to keep it in mind and as part of our strategic plans.
For those of you who have not read the recent guidance document (attached), I wrote a summary of the main points using the text from the guidance.
If you are wise, keep away from it.
Cheers,
Shimon
=======================\\
Overview
1. Section 522 of the Act, 21 U.S.C. § 360l, authorizes FDA to require postmarket surveillance in the following instances:
• a class II or class III device for which failure of the device would be reasonably likely to have a serious adverse health consequence (section 522(a)(1)(A)(i) of the Act);
• a class II or class III device expected to have significant use in pediatric populations (section 522(a)(1)(A)(ii) of the Act);
• a class II or class III device intended to be implanted in the human body for more than one year (section 522(a)(1)(A)(iii)(I) of the Act); or
• a class II or class III device intended to be a life-sustaining or life-supporting device used outside of a user facility (section 522(a)(1)(A)(iii)(II) of the Act)
2. Section 522(a)(1)(A) of the Act specifies that the agency may issue a postmarket surveillance order at the time of device approval or clearance or any time thereafter.
3. The order of prospective postmarket surveillance period can be up to 36 months and sometimes even more.
The process
4. FDA may identify device issues that are appropriate for postmarket surveillance at any point during the life cycle of a device. Such issues may be identified through a variety of sources including analysis of adverse event reports, a recall or corrective action, post-approval data, review of premarket data, reports from other governmental authorities, or review of scientific literature.
5. When FDA identifies a potential issue with a device that may warrant postmarket surveillance, the Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB), Center for Devices and Radiological Health (CDRH) makes a determination regarding whether the statutory requirements for a section 522 order have been met. Next, the Division establishes a cross-Center team (i.e., pre-522 team) to review the issue in greater depth. This team may include FDA epidemiologists, clinicians, or other experts as needed to assess the issue. The pre-522 team evaluates numerous elements with the ultimate goal of making a recommendation to the DEPI Division Director and OSB Director as to whether or not a 522 order should be issued to address a public health question.
6. An order for postmarket surveillance under section 522 of the Act will generally be issued by the OSB Director. The 522 order should identify the premarket submission involved (i.e., 510(k), PMA, PDP, or HDE, or de novo petition), the public health questions, the rationale for the 522 order, and postmarket surveillance design recommendations to assist the manufacturer subject to the 522 order in preparing the postmarket surveillance plan. See 21 CFR 822.5. If a manufacturer disagrees with any order or condition requiring postmarket surveillance under section 522 of the Act, possible recourse options are described in 21 CFR 822.7.
7. FDA will assign a postmarket surveillance (PS) number (i.e., PS######) to each 522 order.
8. A manufacturer must submit a postmarket surveillance plan within 30 days of receipt of the 522 order and commence surveillance not later than 15 months after the day on which FDA issues the 522 order.
9. The general and specific content for a postmarket surveillance submission, including the surveillance plan, is outlined in 21 CFR 822.9 and 822.10. FDA will review all postmarket surveillance submissions and respond within 60 calendar days.
10. If a manufacturer disagrees with FDA about the content of the plan or if the plan is disapproved, possible recourse options are described in 21 CFR 822.22.
11. If a manufacturer wishes to propose a change to an approved postmarket surveillance plan that will affect the nature or validity of the data collected, the manufacturer must obtain FDA approval in writing before making such changes.
12. Failure to comply with a requirement under section 522 of the Act may result in enforcement action by FDA.
13. There are different types of postmarket surveillance: randomized clinical trials, prospective cohort study, retrospective cohort Study, cross-sectional study, enhanced surveillance, active surveillance, comprehensive, linked, registry-based surveillance, meta-analysis, prospective & retrospective study, case control study, bench/lab study, animal study, or other design.
14. As provided at 21 CFR 822.38, manufacturers must submit interim and final reports as specified in an approved postmarket surveillance plan.
15. FDA’s 522 webpage - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm.
Summary
• In a nutshell, it is somewhat similar to the EU post-market clinical follow-up (PMCF) process only a lot more stringent.
• This guidance document authorizes FDA to order manufacturers to do postmart surveillance when one of the criteria set in point #1 are met, and when the agency believes that there is a public health question that must be addressed.
• It's good to keep an eye on FDA's 522 page to see who is getting such an order and way.
• The amount of effort required to fulfill a postmarket surveillance is enormous. It would be wise to keep it in mind and as part of our strategic plans.