Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

FDA Lists Final Guidance on 513(g) Requests for Information

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.

According to the guidance, 513(g) requests pertain to the classification of a particular device or the regulatory requirements that particular device must meet in order to comply with the FDA; 513(g) requests are suitable in instances where manufacturers cannot easily determine which device class is most appropriate for their devices, and would like to confirm their classification decisions with the regulator.

The guidance recommends that interested manufacturers submit two copies of their 513(g) requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER), as well as associated fees for reviewing requests. The following components make up an acceptable 513(g) submission:

Cover Letter: date of 513(g) request, device name, specific questions, submitter’s name and contact information
Device Description: list of materials used in the device, photographs and engineering drawings or samples, summary of device’s operational principles, description of device’s energy requirements and description of similar devices already commercially available in the US
Labeling: any proposed labeling and promotional material for device, or any labeling information for similar devices already marketed in the US

Once the FDA receives a 513(g) request, a response can take up to 60 days. Typical responses to a 513(g) request may include the following:

Whether the product in question is a medical device in accordance with section 201(h) of the Food, Drug & Cosmetics Act, as well as whether the device appears to be Class I, II or III
Whether the product in question does not qualify as a medical device, and if it does or does not fall under FDA jurisdiction
Whether the product in question qualifies as a combination product for which the CDRH or CBER may or may not have primary oversight; consultation with the Office of Combination Products may be necessary

Finally, FDA reviewers may contact companies for additional information related to their 513(g) requests in the event of incomplete submissions. In such cases, firms have 30 days to respond to these requests from the FDA in order to keep their 513(g) process open.

Markets: USATags: 513(g), 513g, CBER, CDRH, FDA, medical device

Author: Stewart EisenhartDate: April 9, 2012

Guidance Released for FDA ISO 13485 Pilot Program

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a new pilot program whereby medical device manufacturers may choose to submit audits of their quality systems compliant with ISO 13485:2003 to the FDA’s Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER).

If FDA reviewers determine that information in a manufacturer’s voluntarily submitted ISO 13485 audit indicates that the firm will not likely produce defective or nonconforming devices, that manufacturer may be relieved of FDA quality system audit requirements for one year.

Any US-based or foreign manufacturer subject to 21 CFR Part 820 requirements is eligible to participate in the new program, under the following conditions:

The manufacturer must submit its ISO 13485 audit report to the FDA within 90 days of the audit’s conclusion
Audits are performed according to ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes” rules
ISO 13485 auditors involved must comply with regulations of a GHTF founding member: Canada, the European Union, Australia or Japan

A qualifying submission to the FDA must include an ISO 13485 audit and audit report satisfying GHTF guidelines; the manufacturer must also submit all ISO 13485 audit reports from the previous two years, its current ISO 13485 certificae, as well as contact details (or those of any authorized US FDA agents), relevant FDA registration numbers and ISO 13485 auditor information. All data submitted to the FDA must be in English, in PDF format, and sent to the FDA via the agency’s eSubmitter system.

If an ISO 13485 data submission is deemed acceptable by FDA reviewers, they will recommend that the manufacturer in question “be removed from the routine work load plan for one year from the last day of the most recent ISO 13485:2003 audit,” according to the guidance. The pilot program officially begins June 5, 2012.

The FDA officially still accepts only quality systems compliant with 21 CFR Part 820 (FDA Good Manufacturing Practice) for medical devices marketed in the US. But this new guidance coincides neatly with the agency’s plan to develop in partnership with Health Canada a single audit program for both the US and Canada—and potentially to expand that program to other GHTF member states. In the meantime, manufacturers having to meet both FDA GMP and ISO 13485 quality system requirements will at least have the chance to reduce their US quality system inspection timetables.

Markets: USATags: 21 CFR Part 820, CBER, CDRH, FDA, FDA GMP, ISO 13485

Author: Stewart EisenhartDate: March 19, 2012

FDA Issues Advisory on Medical Device Components Imported from Japan

The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.

Although the agency has yet to receive any reports of defective products or adverse events related to devices incorporating Japanese components, the notice expresses concern that possibly deteriorating manufacturing conditions in areas most affected by the tsunami, earthquake and nuclear plant meltdown could compromise safety and effectiveness of devices for export to the US market.

Specific CDRH and CBER concerns include radioactive contamination of device components, especially those derived from animal materials; contaminated water supplies causing device defects; less reliable availability of electrical power disrupting manufacturing processes; compromised sterilization procedures needed for some devices; compromised reliability of product performance, particularly for components such as electrical connectors, microprocessors and sensors; and damaged manufacturing facilities causing supply shortages of components and finished devices.

The notice urges device manufacturers and distributors to take added precautions—increased sampling and more rigorous testing of components and raw materials, for example—in order to ensure safety and effectiveness of their devices in accordance with 21 CFR Part 820.

Additional precautions are also recommended for certification of electronic products and components, including:

Assessment of incoming devices and supplies to ensure conformity to specifications and quality requirements
Monitoring of purchasing and acceptance procedures such as inspections and sampling to ensure device and component integrity
Inspection of device power supplies for water damage
Running quality control checks to verify product safety
More thorough assessment of animal-derived products and components such as raw heparin

A complete list of CDRH and CBER recommendations is available on the notice.

If a manufacturer or distributor requires an alternate supplier following these precautionary steps, a Premarket Approval Application Supplement, 21 CFR 814.39 or a new 510(k) for changes to existing devices may be needed. Firms should review 21 CFR Part 807 Subpart B to determine whether they will require alternate suppliers to register and list.

The FDA’s notice comes as European and Australian regulators have also stepped up scrutiny of medical device components and products imported from Japan.