Devices

Groups Suggest Changes to Device Quality System Reg

The Consumer Healthcare Products Association (CHPA) says it supports FDA efforts to harmonize its current medical device Quality System Regulation with international quality management system requirements. In a comment letter, CHPA says it generally agrees with the proposed rule’s approach of incorporating ISO 13485. However, it recommends that FDA address several points of concern:

the proposed one-year transition time may not be sufficient;
include a provision continuing the FDA practice of not reviewing supplier and other internal audit reports;
clarify that in the U.S., data privacy and the protection of health information are subject to separate legal frameworks that are not administered by FDA and would not be reviewed during an inspection;
clarify whether other ISO standards referenced in ISO 13485 are incorporated into the FDA regulation; and
clarify the impact of future revisions to ISO 13485 on the FDA regulation.

The Cook Group commends FDA for its work in harmonizing the regulation of medical devices with an internationally recognized standard. It presents additional comments on areas where the proposed rule creates greater requirements than exist in the current Quality System regulation.

Bristol-Myers Squibb says it is “pleased to see FDA moving toward greater harmonization with ISO 13485, which is widely accepted as a global standard.” The company suggests an extended implementation timeline to ensure a smooth transition and gives line-by-line technical comments.

Finally, Meditech says it is supportive of the proposed rulemaking and has comments on some individual elements of it.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome