Inspections, Samples, Medical Devices Flashcards
FDA Manufacturer Inspections
Inspections of manufacturers, processors, packagers, holders of food, drug, devices, tobacco, cosmetics any factory, warehouse, or establishment and vehicles, equipment, (un)finished material, containers, labelin
- authorized agents present credentials and written notice
- given to owner, operator, or agent in charge
- can enter vehicles for transport
- in reasonable times, w/in reasonable limits, in reasonable manner
- Warrent NOT REQUIRED
FDA Pharmacy Inspections
- FDA can enter, inspect to see if they are manufacturing
- OK: drugs compounded for legit rx by authorized prescriber in usual course of practice
- NOT OK: manufacture, prepare, propagate, compound, process drugs outside of regular course of busines of dispensing or selling drugs
- If manufacturing found, inspection can go to records, files, papers, processes, controls, facilities to see if rx drugs, otc drugs, devices, tobacco are adulterated/misbranded or otherwise violate FDCA
What is not automatically inspected by FDA?
Financial data, sales data (other than shipment), pricing, personnel (other than qualifications of people doing stuff under FDCA), and research data (other than new drugs, abx, devices, tobacco subject to reporting and inspection under FDCA)
-are not included UNLESS owner, operator, agent consents
Drug Samples and Pharmacies
- Retail pharmacies cant legally obtain, possess, or distribute drug sampels
- Institutional pharmacies may possess samples under some conditions
Drug Samples and Practitioners
- Samples can be distributed to practitioners licensed to prescribe the drug or at written request of practitioner, be distributed to hospital pharmacy or other healthcare entity
- Requirements:
1. Licensed practitioner gives signed written request to manufacturer/distributor for drug sample delivery
2. Manufacturer/distributor verifies with state authority that practitioner is licensed/authorized under state law to prescribe
3. Receipt signed by recipient when delivered
4. Receipt returned to manufacturer
5. Required inventories must be kept
Medical Device Definition
Device: instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, other similar/related article including any component of a thing that
- recognized in USP/NF or supplement
- intended for use in dx, cure, mitigation,prevention, treatment of dz or animal
- affects structure or function of body of human or animal
- doesn’t act through chemical action within or on the human/animal body and doesn’t depend on metabolism to achieve primary purpose
* *Intrauterine device releasing hormones is both
Medical Device Classes
Class I: Least potential harm - needles, scissors, latex gloves
Class II: Need more regulation to ensure safety/efficacy - insulin syringes, infusion pumps, thermometers, electric heating pads
Class III: Usually life-sustaining devices posing potential risk of injury/illness and require premarket approval - pacemakers, soft contact lenses, replacement heart valve
Medical Device Tracking
Class II or III devices that fit one of three criteria must be tracked by manufacturer when FDA issues tracking order
3 criteria:
1. device failure could reasonably likely have serious AEs
2. device intended to be implanted for > 1 year
3. device is life-sustaining or life-supporting used outside of a device user facility
Medical Device Reports
Device user facilities, manufacturers, importers, and distributors must report/record AEs to ensure no adulteration or misbranding and are safe/effective
- user facility must report deaths, serious injuries that may have been caused/associated w/ device as well as keep AE files and submit annual summary reports
- manufacturer/importer must report deaths, serious injuries that may have been caused/associated w/ device as well as keep AE files and submit specified F/U reports
- distributor maintains records of incidents but not required to report
