Regulatory Potpourri
Safety Data Sheets are required in the US for hazardous chemicals by this Agency.
What is OSHA ?
This regulatory body is responsible for medical device regulation in Australia.
What is TGA (Therapeutic Goods Australia)?
This is one of the three documents that is released to the public by FDA following a 510(k) clearance that contains a high-level summation of the submission package.
What is the 510(k) Summary ?
What is the name of the new conformity checklist that replaced the Essential Requirements Checklist in the EU MDR.
What are General Safety & Performance Requirements (GSPR) ?
This is the governing WI for change control for legacy STERIS for Regulatory Reps only.
What is RA309, Regulatory Representatives ?
What five countries recognize MDSAP audits for compliance of manufacture quality systems ?
What is Brazil, Japan, US, Canada and Australia ?
This Corporate WI is used by the International Regulatory team as the basis for review / release orders on hold.
What is SCS-149, IRST Hold Release ?
It is the intent of a 510(k) to demonstrate substantial equivalence of the subject device to this.
What is a predicate device ?
This date was the compliance deadline for Switzerland Class I medical device 'labeling' to meet the Swiss Representative / Importer (CH Rep) requirements.
What is August 1, 2023 for Class I devices ?
This group maintains responsibility for making final design approval decisions and resulting actions.
What is the Product Evaluation Committee ?
Under this Act, the US EPA implements regulation of disinfectant products (pesticides).
What is FIFRA ? (Federal Insecticide, Fungicide and Rodenticide Act)
This platform, recently introduced, allows team members to view the regulatory status of international registration healthcare requests.
What is the NPI (New Product Introduction) Smartsheet system under Corporate WI SCS-173 ?
This is the section of a device's 510(k) containing the device claims that FDA actually "clears".
What is the Indications for Use ?
This is how many days manufacturers have to report serious adverse events under the EU MDR.
What is fifteen (15) days ?
This is the governing process for change control across legacy STERIS for the cross functional teams.
What is C02, Engineering Change Control process ?
This is the stage of development that is typically not reviewable by regulatory agencies during audits / inspections.
What is Feasibility ?
This country, located in LATAM, requires an additional certification (ANATEL) for medical devices with telecommunication properties ?
What is Brazil ?
It is considered the non-substantive initial review period of a 510(k) that is officially 'going away' in October.
What is Refuse to Accept (RTA) ?
What is the full name of the EU hazardous chemical regulation commonly called REACH.
What is the Registration, Evaluation, Authorisation and Restriction of chemical substances ?
What Regulatory team member is the PEC Chair.
Daily Double: Who is Bill Brodbeck ?
What classification is assigned by Health Canada to STERIS disinfectant products ?
What is a Drug ?
This country in the Asia/Pacific region strictly requires CB Scheme testing to support electrical safety of Class II devices.
What is Korea ?
This is the type of 510(k) that is required if making a change to an existing indication for use and utilizing new test methods.
What is a Traditional 510(k) ?
What EU Regulation governs the placement on the market of active ingredients found in and finished goods that are classified as Biocide products ?
Daily Double: What is the BPR, Biocidal Products Regulation ?
This the 'primary' group of countries that are considered for potential regulatory impact for all design changes.
What are the MDSAP countries ?