Regulations
Unlike voluntary standards, regulations are a hard requirement to follow and are mandated by an Authority Having Jurisdiction. Unless you have a specific exemption regulations demand complete compliance. (Not to say that an AHJ can’t also require compliance with a guidance document full of ‘nonbinding recomendations’. They make the rules…)
The screenshot above shows an example of a regulatory exemption from the FDA. By default, all Class II and Class III devices must have established and maintained process controls for Design Controls. Class I devices are exempt from this requirement unless they meet the criteria of 21 CFR 820.30 Design Controls (a)(2)(i), or (ii).
How does this affect your audit program? If you are not exempted, you will need to include this process to be audited under your program. If not, you should be able to provide a rationale within your audit report.
It might even look something like this, “[Insert Device Name], as the only device manufactured by [Insert Company Name], is a Class I device not automated by computer software or listed on the Design Controls chart under 21 CFR 820.30 Design Controls and is therefore exempt from the requirements of that part under Title 21 of the Code of Federal Regulations.”.
Of course this only applies to the jurisdiction of the U.S. FDA. Health Canada, or ISO may not care what excemptions the FDA allows for under manufacturer quality systems. It is up to the manufacturer to manage the scope and criteria of their own audit program. This would be an example of a rationale for exclusion of a particular Subpart of the QSR from being included as audit criteria.
Below is a list of some of the common jurisdictional authorities and their regulations as well as URLs to veiw them.
U.S. FDA – Title 21 of the Code of Federal Regulations Section 820 Quality System Requirements – https://www.ecfr.gov/cgi-bin/text-idx?SID=26928f38f89986d7dabfd6d519d90f4a&mc=true&node=pt21.8.820&rgn=div5
U.S. FDA – Title 21 of the Code of Federal Regulations Section 801 Labeling – https://www.ecfr.gov/cgi-bin/text-idx?SID=26928f38f89986d7dabfd6d519d90f4a&mc=true&node=pt21.8.801&rgn=div5
U.S. FDA – Title 21 of the Code of Federal Regulations Section 803 Medical Device Reporting – https://www.ecfr.gov/cgi-bin/text-idx?SID=26928f38f89986d7dabfd6d519d90f4a&mc=true&node=pt21.8.803&rgn=div5
U.S. FDA – Title 21 of the Code of Federal Regulations Section 806 Medical Devices; Reports of Corrections and Removals – https://www.ecfr.gov/cgi-bin/text-idx?SID=26928f38f89986d7dabfd6d519d90f4a&mc=true&node=pt21.8.806&rgn=div5
NOTE: The above links are for the e-CFR and are active as of creating this course (July/August of 2021). The FDA at that time has begun beta testing a new format and web delivery of the e-CFR at https://ecfr.federalregister.gov/
Health Canada – Medical Devices Regulations (SOR/98-282) – https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/
Participaing Member States of the European Union – Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices – https://eur-lex.europa.eu/eli/reg/2017/746/oj
Participaing Member States of the European Union – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – https://eur-lex.europa.eu/eli/reg/2017/745/oj