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gramaley
FDA RECOGNITION OF ISO 13485 – THE REASONS FOR AND AGAINST
There has been a lot of pressure on the FDA to explore recognition of ISO 13485. After all, the FDA belongs to TC 210, which rewrote ISO 13485:2003 to address a lot of FDA requirements in Part 820. The FDA even conducts some ISO 13485 awareness training for new FDA inspectors. The FDA has stated that ISO 13485 covers at least 90% of the QSR. Given that the FDA is so far behind on performing QSR inspections, one must wonder why they had not adopted ISO 13485 as a recognized standard.
The FDA is concerned about the legitimacy of ISO 13485 audits, and for good reason. Not all ISO certificates are as credible as they should be. However, not performing inspections at all is a far worse threat to public health. That is why the FDA has to explore using ISO 13485 in some capacity.
GAO REPORT ON FDA FOREIGN INSPECTION – One inspection every 27 years!
The most recent Government Accountability Office's report on FDA inspections indicates that foreign medical device manufacturers get inspected on average; once in 27 years, and just once in 6 years for the highest risk devices. Foreign manufacturers who think US manufacturers have an upper hand in trade to our region are not aware of this reality. You can download and read the report yourself (Google “GAO report FDA inspections”). I don't have enough "post counts" on this website to provide any links. I apologize. Please add them.
FDA RESISTANCE TO ISO 13485 and FAILURE of the THIRD PARTY CAB PROGRAMS
There has long been a tremendous resistance by the FDA to using anything other than the Quality System Inspection Technique (QSIT) for “audits”. However, two noteworthy attempts to introduce FDA inspections through third party CABs have been attempted, but met with utter failure. The first attempt occurred under the EU/US MRA. The second attempt has occurred with Canada under the Pilot Multipurpose Audit Program (PMAP) In both cases European, Canadian and even US manufacturers that looked into these programs found that their regular CE or ISO 13485 CMDCAS audits were going to have several more days added to them to cover FDA Part 820 (Quality System Regulation). Under the EU/US MRA and now under PMAP, these audits appear at first to be one audit. In reality, they are two audits conducted at the same time; a QSIT inspection conducted together with either a "CE" QS audit or ISO 13485 CMDCAS audit. The first attempt by FDA to use third party auditors for QSIT occured in Europe and failed miserably. Of 5000 companies that were invited to use the Third Party system under the EU/US MRA attracted fewer than 10 companies.
FDA PMAP and PRESSURE ON INDUSTRY
In a more recent attempt with Canada, which is still ongoing, the FDA has created a list of 300+ companies that have ISO 13485 CMDCAS certificates, (which they got from Health Canada). The FDA contacted these companies; especially of they had not had a recent FDA inspection, and explained that they were overdue for an FDA inspection and eligible for to participate in the new Pilot Multipurpose Audit Program (PMAP). The benefit being they would not undergo a full blown FDA inspection using regular US FDA inspectors.
The target companies were offered an opportunity to escape the FDA’s regular inspection if they participated in PMAP. Keep in mind, most companies in Canada have never seen an FDA inspector, if the GAO report is true. As a result, less than a 6 companies volunteered to participate. When the FDA saw they weren’t attracting interest, they called the companies and told them they were going to get an FDA inspection. As many as 30 more companies then signed up out of the 300, but only under what was perceived to be an unveiled threat. FDA QSIT audits can range from 5-30 days, depending on a number of factors. PMAP audits are shortened to one week. However, many ISO 13485 certified companies are concerned they may not pass a QSIT audit. Many ISO 13485 companies do not specifically address Device History Record requirements and more robust “Complaint File” requirements that only exist in the QSR. Company’s that do address these sections in their ISO 13485 oriented QMS should do alright. Manufactures still continue to remain very uneasy with QSIT.
ISO 13485’s IMPACT ON ROUTINE FDA INSPECTIONS
ISO 13485 certification should greatly help the FDA adjust its inspection priorities. Routine inspection priorities should be impacted by a company’s ability to produce a credible ISO 13485 certificate. The FDA’s “risk-based” approach to setting inspection priorities should then shift FDA inspection resources to areas that pose a greater risk to public health. This would be aided if ISO 13485 certificates were more credible and the auditing more transparent.
THE FUTURE OF ISO 13485 CERTIFICATION
At this moment a new ISO 13485 accredited certification program for medical device manufacturer is being developed. It is specifically designed as an Accredited Certification program for ISO 13485. It is being development at the International Accreditation Forum .iaf.nu. There is an article on the new IAF Medical Device Conformity Assessment System on the internet at MD&DI titled: “Nations May Soon Have Out-of-the-Box Auditing Option”. I’d appreciate it if someone could post a link to it for me, since I cannot. The program was recently re-titled MDCAS; from its previous name GMDCAS, for foreign language purposes. They are one and the same program.
THE INTRACTABLE LINK OF HEALTHCARE AND MEDICAL DEVICE TRADE
This is a concern for all medical device industry. Already we have witnessed ISO 13485-type QMS audits being required under national regulations (e.g. Canada, Japan, Taiwan, Brazil to name a few). Many more countries are heading in the same direction. This has had a real adverse impact on healthcare systems. Numerous safe and effective medical devices are now illegal in some of these countries. Preventing healthcare professionals from getting hold of vital tools they need to treat their patients has been grossly underestimated by regulators. Those that are responsible for protecting the public health have inadvertently caused unnecessary harm to the healthcare systems they have an obligation to protect. This adverse impact is multiplied several fold when smaller economies that are more heavily reliant on imported devices do the same, but nearly all countries import more medical devices than they export. It affects them all. This is a huge world health concern that is directly linked to a barrier to trade – failure to recognize ISO 13485 certificates.
IAF MEDICAL DEVICE CONFORMITY ASSESSMENT SYSTEM (MDCAS)
The IAF working group for the medical device is currently promoting awareness of the new accredited ISO 13485 certification program it is developing, yes, even before it is completed. We need to stem the tide of national versions of the same ISO 13485 certification systems that would undermine their healthcare objectives. I've had numerous conversations with representatives from many different countries and the prospects are excellent for the new IAF MDCAS accreditation program, especially in developing countries that want to adopt the GHTF guidance. We also have a great deal of direct support in our working group from BSI, TUV, LNE and UL. They are all participating in shaping this program for much the same reasons industry is concerned. CABs cannot continue to carry a separate accreditation for each and every country that wants one. An internationally accredited ISO 13485 certification program must first be developed. Harmonization is nothing without a system for Recognition. This is a system for recognition based on harmonized GHTF guidance and ISO standards.
MORE CREDIBILITY, MORE TRANSPARENCY, MORE ACCEPTANCE
Using the IAF MDCAS will allow greater transparency into ISO 13485 certified companies. Regulatory authorities that participate in the program by acknowledging ISO 13485 IAF MDCAS certificates in their medical device regulations will also have access to audit reports from ABs, CABs in addition to the audit report of the medical device manufacturer. All they must do to activate their participation is add the ISO 13485 IAF-MDCAS certificate to their medical device regulation and contact a participating ABs and CABs involved in the accreditation and certification activities. This program is commited to serving countries need a more credible ISO 13485 certificate to support their medical device regulations.
Further benefits from IAF MDCAS could be utilized as ISO 13485 auditors are more likely to speak the foreign tongue of the manufacturer’s personnel. How many Chinese, Swahili or Arabic speaking inspectors does the FDA have? The GAO report emphasizes this as one of the FDA’s greatest challenges. We all know it as an area of difficulty for many CABs as well. The IAF has more than 50 countries involved to provide a great deal more diversity in cultural and language barriers that are often too difficult to overcome during audits.
The new IAF Medical Device Conformity Assessment System will improve the credibility and transparency of ISO 13485 certification audits. This program will best serve medical device’s global demand for mutual acceptance of ISO 13485 certification. IAF MDCAS also enforces the guidance of the Global Harmonization Task Force SG-4. Medical Device Regulators must become more aware that using the existing ISO 13485 standard in a more broadly accepted and credible way, is the best way to sustain its healthcare system's need for medical devices, while adding protection for public health that does not deviate from what manufacturers have grown accustom to.
Grant Ramaley
Chairman
Regulatory Affairs and Standards Committee
Dental Trade Alliance
Convener for IAF Working Group
ISO 13485 Medical Device Conformity
Assessment System (IAF-MDCAS)
There has been a lot of pressure on the FDA to explore recognition of ISO 13485. After all, the FDA belongs to TC 210, which rewrote ISO 13485:2003 to address a lot of FDA requirements in Part 820. The FDA even conducts some ISO 13485 awareness training for new FDA inspectors. The FDA has stated that ISO 13485 covers at least 90% of the QSR. Given that the FDA is so far behind on performing QSR inspections, one must wonder why they had not adopted ISO 13485 as a recognized standard.
The FDA is concerned about the legitimacy of ISO 13485 audits, and for good reason. Not all ISO certificates are as credible as they should be. However, not performing inspections at all is a far worse threat to public health. That is why the FDA has to explore using ISO 13485 in some capacity.
GAO REPORT ON FDA FOREIGN INSPECTION – One inspection every 27 years!
The most recent Government Accountability Office's report on FDA inspections indicates that foreign medical device manufacturers get inspected on average; once in 27 years, and just once in 6 years for the highest risk devices. Foreign manufacturers who think US manufacturers have an upper hand in trade to our region are not aware of this reality. You can download and read the report yourself (Google “GAO report FDA inspections”). I don't have enough "post counts" on this website to provide any links. I apologize. Please add them.
FDA RESISTANCE TO ISO 13485 and FAILURE of the THIRD PARTY CAB PROGRAMS
There has long been a tremendous resistance by the FDA to using anything other than the Quality System Inspection Technique (QSIT) for “audits”. However, two noteworthy attempts to introduce FDA inspections through third party CABs have been attempted, but met with utter failure. The first attempt occurred under the EU/US MRA. The second attempt has occurred with Canada under the Pilot Multipurpose Audit Program (PMAP) In both cases European, Canadian and even US manufacturers that looked into these programs found that their regular CE or ISO 13485 CMDCAS audits were going to have several more days added to them to cover FDA Part 820 (Quality System Regulation). Under the EU/US MRA and now under PMAP, these audits appear at first to be one audit. In reality, they are two audits conducted at the same time; a QSIT inspection conducted together with either a "CE" QS audit or ISO 13485 CMDCAS audit. The first attempt by FDA to use third party auditors for QSIT occured in Europe and failed miserably. Of 5000 companies that were invited to use the Third Party system under the EU/US MRA attracted fewer than 10 companies.
FDA PMAP and PRESSURE ON INDUSTRY
In a more recent attempt with Canada, which is still ongoing, the FDA has created a list of 300+ companies that have ISO 13485 CMDCAS certificates, (which they got from Health Canada). The FDA contacted these companies; especially of they had not had a recent FDA inspection, and explained that they were overdue for an FDA inspection and eligible for to participate in the new Pilot Multipurpose Audit Program (PMAP). The benefit being they would not undergo a full blown FDA inspection using regular US FDA inspectors.
The target companies were offered an opportunity to escape the FDA’s regular inspection if they participated in PMAP. Keep in mind, most companies in Canada have never seen an FDA inspector, if the GAO report is true. As a result, less than a 6 companies volunteered to participate. When the FDA saw they weren’t attracting interest, they called the companies and told them they were going to get an FDA inspection. As many as 30 more companies then signed up out of the 300, but only under what was perceived to be an unveiled threat. FDA QSIT audits can range from 5-30 days, depending on a number of factors. PMAP audits are shortened to one week. However, many ISO 13485 certified companies are concerned they may not pass a QSIT audit. Many ISO 13485 companies do not specifically address Device History Record requirements and more robust “Complaint File” requirements that only exist in the QSR. Company’s that do address these sections in their ISO 13485 oriented QMS should do alright. Manufactures still continue to remain very uneasy with QSIT.
ISO 13485’s IMPACT ON ROUTINE FDA INSPECTIONS
ISO 13485 certification should greatly help the FDA adjust its inspection priorities. Routine inspection priorities should be impacted by a company’s ability to produce a credible ISO 13485 certificate. The FDA’s “risk-based” approach to setting inspection priorities should then shift FDA inspection resources to areas that pose a greater risk to public health. This would be aided if ISO 13485 certificates were more credible and the auditing more transparent.
THE FUTURE OF ISO 13485 CERTIFICATION
At this moment a new ISO 13485 accredited certification program for medical device manufacturer is being developed. It is specifically designed as an Accredited Certification program for ISO 13485. It is being development at the International Accreditation Forum .iaf.nu. There is an article on the new IAF Medical Device Conformity Assessment System on the internet at MD&DI titled: “Nations May Soon Have Out-of-the-Box Auditing Option”. I’d appreciate it if someone could post a link to it for me, since I cannot. The program was recently re-titled MDCAS; from its previous name GMDCAS, for foreign language purposes. They are one and the same program.
THE INTRACTABLE LINK OF HEALTHCARE AND MEDICAL DEVICE TRADE
This is a concern for all medical device industry. Already we have witnessed ISO 13485-type QMS audits being required under national regulations (e.g. Canada, Japan, Taiwan, Brazil to name a few). Many more countries are heading in the same direction. This has had a real adverse impact on healthcare systems. Numerous safe and effective medical devices are now illegal in some of these countries. Preventing healthcare professionals from getting hold of vital tools they need to treat their patients has been grossly underestimated by regulators. Those that are responsible for protecting the public health have inadvertently caused unnecessary harm to the healthcare systems they have an obligation to protect. This adverse impact is multiplied several fold when smaller economies that are more heavily reliant on imported devices do the same, but nearly all countries import more medical devices than they export. It affects them all. This is a huge world health concern that is directly linked to a barrier to trade – failure to recognize ISO 13485 certificates.
IAF MEDICAL DEVICE CONFORMITY ASSESSMENT SYSTEM (MDCAS)
The IAF working group for the medical device is currently promoting awareness of the new accredited ISO 13485 certification program it is developing, yes, even before it is completed. We need to stem the tide of national versions of the same ISO 13485 certification systems that would undermine their healthcare objectives. I've had numerous conversations with representatives from many different countries and the prospects are excellent for the new IAF MDCAS accreditation program, especially in developing countries that want to adopt the GHTF guidance. We also have a great deal of direct support in our working group from BSI, TUV, LNE and UL. They are all participating in shaping this program for much the same reasons industry is concerned. CABs cannot continue to carry a separate accreditation for each and every country that wants one. An internationally accredited ISO 13485 certification program must first be developed. Harmonization is nothing without a system for Recognition. This is a system for recognition based on harmonized GHTF guidance and ISO standards.
MORE CREDIBILITY, MORE TRANSPARENCY, MORE ACCEPTANCE
Using the IAF MDCAS will allow greater transparency into ISO 13485 certified companies. Regulatory authorities that participate in the program by acknowledging ISO 13485 IAF MDCAS certificates in their medical device regulations will also have access to audit reports from ABs, CABs in addition to the audit report of the medical device manufacturer. All they must do to activate their participation is add the ISO 13485 IAF-MDCAS certificate to their medical device regulation and contact a participating ABs and CABs involved in the accreditation and certification activities. This program is commited to serving countries need a more credible ISO 13485 certificate to support their medical device regulations.
Further benefits from IAF MDCAS could be utilized as ISO 13485 auditors are more likely to speak the foreign tongue of the manufacturer’s personnel. How many Chinese, Swahili or Arabic speaking inspectors does the FDA have? The GAO report emphasizes this as one of the FDA’s greatest challenges. We all know it as an area of difficulty for many CABs as well. The IAF has more than 50 countries involved to provide a great deal more diversity in cultural and language barriers that are often too difficult to overcome during audits.
The new IAF Medical Device Conformity Assessment System will improve the credibility and transparency of ISO 13485 certification audits. This program will best serve medical device’s global demand for mutual acceptance of ISO 13485 certification. IAF MDCAS also enforces the guidance of the Global Harmonization Task Force SG-4. Medical Device Regulators must become more aware that using the existing ISO 13485 standard in a more broadly accepted and credible way, is the best way to sustain its healthcare system's need for medical devices, while adding protection for public health that does not deviate from what manufacturers have grown accustom to.
Grant Ramaley
Chairman
Regulatory Affairs and Standards Committee
Dental Trade Alliance
Convener for IAF Working Group
ISO 13485 Medical Device Conformity
Assessment System (IAF-MDCAS)
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