NCHR Comments on Quality System Regulation Amendments for Medical Devices

May 24, 2022

The National Center for Health Research appreciates the opportunity to comment on the FDA proposed rule regarding Medical Devices; Quality System Regulation Amendments.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. This would save corporations money by eliminating some redundancy. It therefore has the potential for getting devices on the U.S. market somewhat more quickly.  However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.

  1.  FDA standards tend to be higher than the standards in other countries.  Unfortunately, we would expect that changing FDA standards to harmonize with international standards is likely to harm patients and consumers by reducing safeguards that currently exist.  What assurance can FDA provide that safeguards will be higher rather than lower as a result of the proposed harmonization?
  2. The proposed rule states that “The more flexible approach to quality, based on risk management, found within ISO 13485 will meet the needs of patients to have access to quality devices in consonance with the progress of science and technology.”  This apparently refers to speed of access, rather than the quality of devices.  This change in FDA practices to being more risk-based is of concern to patients and consumers, because risk is often very difficult to predict, as clearly shown when many widely used devices have been recalled or “voluntarily withdrawn” from the market due to irreparable harm to adults and children.  Moreover, it is unclear how risk would be determined in this system or whether inspections would change based on perceived risk.
  3. The proposed rule states that “Although this rule does not impact FDA’s authority to conduct inspections under section 704 of the FD&C Act, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the proposed part 820 as finalized. Similar to the current QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and those included on a Form FDA 483, as appropriate and necessary. FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485. In addition, manufacturers with a certificate of conformance to ISO 13485 are not exempt from FDA inspections.”  These assurances do not adequately explain to the public or policy makers, in plain English, how the proposed changes will specifically affect the standards for inspections and the extent to which inspections would be more or less likely to identify serious shortcomings and result in stronger or weaker safeguards for patients.
  4. CDRH does not have its own working quality system that will prevent, find, or correct mistakes in CDRH processes. It seems that the proposed rule would not improve that situation.

In summary, the proposed rule is geared toward meeting the needs of industry, rather than the needs of patients and consumers to ensure safe and effective medical devices.  For example, the medical device harmonization that is most important to patients and consumers would be to strengthen PMA standards to be more consistent with CDER approval standards, by requiring randomized controlled trials. This would help address the current problem where physicians and patients rely on FDA approval of high-risk devices as being based on much higher scientific standards than CDRH requires.  In addition, patients and consumers would greatly benefit if PMA studies included subgroup analyses of a substantial number of people over 65, since the risks and benefits from medical devices are often very different for older, frailer people compared to younger people.  This would also result in better harmonization with CMS than currently exists, by raising FDA standards for approval rather than lowering Medicare standards for coverage.  Instead, CDRH has made it clear that harmonization is focused on pleasing their “most important customer” — the device industry — rather than the American taxpayer that relies on the FDA to ensure the safety and effectiveness of all medical devices.

The National Center for Health Research can be reached at or at (202) 223-4000.